BECTON DICKINSON MEDICAL SYSTEMS 3ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML; PREFILLED HEPARIN FLUSH SYRINGE
|
Back to Search Results |
|
Catalog Number 306521 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Unspecified Infection (1930)
|
Event Date 04/13/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple potential lot numbers were provided for this incident.The information for each lot number is as follows: medical device lot #: 719291n, medical device expiration date: 1/10/2019, device manufacture date: 7/17/2017.Medical device lot #: 726971n, medical device expiration date: 3/25/2019, device manufacture date: 9/29/2017.Medical device lot #: 726391n, medical device expiration date: 3/19/2019, device manufacture date: 9/26/2017.Medical device lot #: 726472n, medical device expiration date: 3/20/2019, device manufacture date: 9/26/2017.Medical device lot #: 718091n, medical device expiration date: 12/2/2018,.Device manufacture date: 7/8/2017 medical device lot #: 721481n, medical device expiration date: 2/1/2019, device manufacture date: 8/8/2017.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported that infections associated with central lines and the use of a 3 ml bd posiflush¿ heparin lock flush syringe, in 10 ml syringe, 10 usp units/ml were being investigated by the fda.There was no evidence that the bd device is implicated but all sources and common products are being investigated.
|
|
Manufacturer Narrative
|
Correction: type of report: the initial mdr was submitted as a 30-day report.Bd has changed our position on this incident and we are making a correction to report the mdr as a 5-day report.
|
|
Event Description
|
It was reported that infections associated with central lines and the use of a 3 ml bd posiflush¿ heparin lock flush syringe, in 10 ml syringe, 10 usp units/ml were being investigated by the fda.There was no evidence that the bd device is implicated but all sources and common products are being investigated.
|
|
Manufacturer Narrative
|
H.6.Lot numbers 718091n, 719291n, 721481n, 726391n, 726472n, and 726971n for product code 306521 were provided for evaluation by our quality engineer team.Upon reviewing the production history for the provided lot numbers, no deviations or non-conformances were identified during the manufacturing process.A corrective and preventive action plan was initiated to further investigate and monitor this issue.One-hundred and twenty retained samples for each lot number provided were visually inspected and no abnormalities were observed in regards to the solution.Forty retained samples for each lot number provided were sent for sterility testing.The sterility testing confirmed that the samples exhibited no microbial growth after incubation.A direct causation between the reported infections and the bd (b)(4) product has not been identified.Prior to the report of infection evaluated in (b)(4), there was no trend for infection cases reported for (b)(4) product.The complaint is part of a new trend which began in april 2018.Capa 350041 was initiated to address this issue.
|
|
Search Alerts/Recalls
|
|
|