MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE; PREFILLED HEPARIN FLUSH SYRINGE

Catalog Number UNKNOWN

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

A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, (b)(4) has been listed and (b)(4) fda registration number has been used for the manufacture report number.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 an unspecified bd posiflush¿ heparin lock flush syringe 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

Investigation summary: 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 april 2018, there was no trend for infection regarding the bd franklin products.Upon the increase of infection reports beginning in april 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.Investigation conclusion: unknown ¿ 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 april 2018.Capa (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.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.Conclusion(s): 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: UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
• Type of Device: PREFILLED HEPARIN FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7467628
• MDR Text Key: 106701360
• Report Number: 2243072-2018-00220
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 04/13/2018; 04/13/2018
• Supplement Dates FDA Received: 05/01/2018; 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other