MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SYRINGE; PRE-FILLED SYRINGE

Catalog Number 306594

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

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 the labels on 2 the bd posiflush¿ syringes' barrels were noticed to be missing after opening their unit packaging.

Manufacturer Narrative

H.6.Investigation summary: two samples were received for evaluation.Both samples have the barrel label missing therefore failure mode is verified.This was due to a process variation of the plunger rod labeler machine.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.This is the 1st complaint for the lot# 8045566 for the same defect or symptom.There was no documentation of issues for the complaint of batch #8045566 during the production run.

Event Description

It was reported that the labels on 2 the bd posiflush¿ syringes' barrels were noticed to be missing after opening their unit packaging.

• Brand Name: BD POSIFLUSH¿ SYRINGE
• Type of Device: PRE-FILLED SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8294426
• MDR Text Key: 134714103
• Report Number: 1911916-2019-00132
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 306594
• Device Lot Number: 8045566
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other