Alerta De Seguridad para BD VACUTAINER BRAND LUER ADAPTER - Registered in Anvisa under the number 10033430348 - AFFECTED LOTS: Until May / 2013: 2051816; 2061437; 2061438; 2061448; 2061449; 2108592; 2121718; 2123785; 2123786; 2199845; 2213779; 2226823; 2263906; 2277686; 2277687; 2311696; 2311698; 2319540; 2332684; 2333888; 2342733; 3017549; 3030976. See annex: http://portal.anvisa.gov.br/wps/wcm/connect/8ce775004fbab18bb190f59a71dcc661/AnexoII_MensagemdeAlerta.pdf?MOD=AJPERES

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

BD Vacutainer Brand Luer Adapter is a noninvasive product used to attach venous access devices such as needles, scalpels and catheters to blood collection tubes. The BD through the monitoring of market complaints in the world triggered an investigative analysis associated with the function of the rubber sleeve and the luer connector. In case of leakage, the risk of exposure to blood is mitigated through the use of universal precautionary techniques. If the health professional is not adopting such techniques, there could be contact with the blood. If the blood was from a patient who is a source of pathogens, tests may be needed to rule out viral transmission and prophylaxis - in the case of HBV or HIV - with vaccines and medications. This situation associated with the occurrence rate (12.01 per 1,000,000 devices) results in an acceptable risk index. Exposure would very rarely result in viral transmission, since according to the literature this almost never occurs through exposure of non-intact skin and rarely via mucosa. Thus, the probability of acquiring a disease such as AIDS or chronic hepatitis is very low and unlikely (0.0123 per 1,000,000) and therefore the resulting risk score is acceptable. The risk of low aspiration volume in coagulation tubes is mitigated by discarding of the tube when observed leakage or by rejection of the samples collected in these tubes, since laboratory guidelines and instructions specify that collections with less than 10% of the nominal volume do not should be tested for coagulation assays. The low volume of aspiration in coagulation tubes could affect the precision of the results and possibly influence the medical analysis. In this event, the probability of a treatment being influenced is very low and unlikely (0.145 per 1,000,000) and therefore, the resulting risk score is acceptable. To date, no technical complaints or adverse events related to the product have been reported in NOTIVISA. ////// UPDATE ON 05/27/2014 - The company forwarded a form to complete this field action, ending the process of communication with customers for this security action.