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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 04/13/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event 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.

Manufacturer Narrative

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.

Manufacturer Narrative

As both a lot number and sample were unavailable for this incident, a full investigation consisting of a sample analysis and a device history record review could not be completed.Prior to (b)(6) 2018, there was no trend for infection regarding the bd franklin products.Upon the increase of infection reports beginning in (b)(6) 2018, a corrective and preventive action plan was initiated to address the issue.A review of all lot sterility testing performed for product released between april 2015 and may 2018 confirmed that no organism growth was identified for any lots released during the shelf life of this product.A direct causation between the reported infections and the bd franklin product has not been identified.Lot number was not provided.Prior to the report of infection evaluated in (b)(4), there was no trend for infection cases reported for franklin product.This complaint is part of a new trend which began in (b)(6) 2018.(b)(4) was initiated to address this issue.As no lot number was provided, a dhr review could not be completed.Quantity of retained samples used for testing: 0 ¿ although retain samples are available for all lots manufactured in franklin, as the lot number was not provided, retain samples were not tested.Samples and/or pictures were not provided for evaluation.A review of all lot sterility testing performed for product released between april 2015 & may 2018 confirmed that no organism growth was identified for any lots released during the shelf-life of this product.The root cause analysis of the reported infection cases under (b)(4) has not identified a direct causation between the infections and the (b)(6) product.

• Brand Name: 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 100 USP UNITS/ML
• Type of Device: PREFILLED HEPARIN FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7467626
• MDR Text Key: 106699458
• Report Number: 2134319-2018-00003
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065135
• UDI-Public: 30382903065135
• Combination Product (y/n): N
• PMA/PMN Number: K011967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 306513
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other