Alerta De Seguridad para Vital-Port Vascular Access Systems

Safety alert

2017-12-05

2017-12-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20171205.html

Medical device safety alert: cook medical vital-port vascular access systems medical device manufacturer, cook medical, has issued a medical device safety alert concerning its vital-port vascular access systems (vital-port). the affected devices are:- vital-port vascular access system titanium power injectable single-chamber systems catalogue identifier: ip-7110, ip-s7010, ip-s7110, ip-s9010, ip-s9110; gpn: g20254, g26434, g26436, g26438, g26440; all lots vital-port vascular access system standard, petite and mini titanium and mri single-chamber systems catalogue identifier: ip-5112-n, ip-5112-nc, ip-5116, ip-5116-n, ip-5118-n, ip-5118-nc, ip-6018, ip-6113, ip-7112, ip-9112, ip-s5016, ip-s5018, ip-s5116, ip-s5116-mpis-nt, ip-s5116-n, ip-s5116w, ip-s5116w-mpis-nt, ip-s5118, ip-s5118-n, ip-s6010, ip-s6012, ip-s6013, ip-s6018, ip-s6110, ip-s6112, ip-s6113, ip-s6113-mpis-nt, ip-s6118, ip-s6118-mpis-nt, ip-s7012, ip-s7112, ip-s9012, ip-s9112; gpn: g46543, g26539, g26468, g46544, g46545, g26540, g26510, g26424, g19803, g19769, g26469, g26507, g26470, g50864, g46546, g26472, g26489, g26509, g46547, g26430, g26458, g26431, g26511, g26432, g26449, g26433, g50860, g26513, g50861, g26435, g26437, g26439, g26441; all lots vital-port vascular access system standard and petite titanium dual-chamber systems catalogue identifier: ip-s1021, ip-s1121, ip-s7029, ip-s7129, ip-s7129-mpis-nt; gpn: g26428, g26429, g26502, g26504, g50863; all lots the manufacturer is initiating a voluntary recall of the products listed above. during testing of the non-coring needle, the manufacturer has identified that the non-coring needle provided with the cook vital-port may cut or dislodge a core or sliver of material from the vital-port septum when the non-coring needle is inserted into the vital-port. this needle is used on the initial implant of the vital-port. vital-port products that have been successfully placed in patients are not impacted by this recall. according to the manufacturer, potential adverse events that may occur are unwanted side effects from silicone cores or slivers that may embolise into the patients’ bloodstream. in addition, medications may leak from the port, resulting in inadequate delivery of the medication and potential injury to the surrounding tissues. there have been no adverse event reports from septum leakage or a silicone sliver pushed into the patient associated with these products to date. the manufacturer is advising users to examine inventory immediately to determine if they have affected products and quarantine affected products. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 december 2017.