MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML; PREFILLED HEPARIN FLUSH SYRINGE

Catalog Number	306521
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional Manufacturer Narrative
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 franklin product has not been identified.Prior to the report of infection evaluated in (b)(4), there was no trend for infection cases reported for franklin product.The complaint is part of a new trend which began in april 2018.Capa (b)(4) was initiated to address this issue.

• Brand Name: 3ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML
• Common Device Name: PREFILLED HEPARIN FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7467621
• Report Number: 2134319-2018-00006
• Device Sequence Number: 11061711
• Product Code: FOZ
• UDI-Device Identifier: 30382903065210
• UDI-Public: 30382903065210
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K011967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: 306521
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 04/13/2018; 04/13/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 05/01/2018; 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other