MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 100 USP UNITS/ML; PREFILLED HEPARIN FLUSH SYRINGE

Catalog Number	306513
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 #: 716192n medical device expiration date: 6/9/2019 device manufacture date: 6/15/2017 medical device lot #: 718711n medical device expiration date: 7/5/2019 device manufacture date: 7/8/2017 medical device lot #: 718611n medical device expiration date: 7/4/2019 device manufacture date: 7/7/2017 medical device lot #: 725181n medical device expiration date: 9/7/2019 device manufacture date: 9/12/2017 medical device lot #: 725271n medical device expiration date: 9/8/2019 device manufacture date: 9//12/2017 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 5 ml bd posiflush¿ heparin lock flush syringe, in 10 ml syringe, 100 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 5 ml bd posiflush¿ heparin lock flush syringe, in 10 ml syringe, 100 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
H.6.Investigation summary: lot: 725181n & 725271n & 716192n & 718711n & 718611n.There were no deviations, non-conformances, or out of specifications related to the manufacture of lot 725181n or the raw materials used to manufacture this lot.This complaint is part of a new trend which began in (b)(6) 2018.Capa (b)(4) was initiated to address this issue.100% of retained samples for the lot ((b)(4) units) were visually inspected.No growth was seen (i.E., solution was clear).(b)(4) units of the retained samples were sent to nelson laboratories, inc.For sterility testing in may 2018.The sterility testing was performed in an isolator per usp 71 membrane filtration method.Per the attached lab report, after incubation, the retained samples exhibited no microbial growth.Investigation conclusion: the root cause analysis of the reported infection cases under capa (b)(4) has not identified a direct causation between the infections and the bd franklin product.

• Brand Name: 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 100 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: 7467625
• Report Number: 2134319-2018-00008
• Device Sequence Number: 1273449
• Product Code: FOZ
• UDI-Device Identifier: 30382903065135
• UDI-Public: 30382903065135
• 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): 08/07/2018

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: 306513
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018; 04/10/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 05/01/2018; 08/07/2018
• 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