MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; INTRAVASCULAR CATHETER

Catalog Number 306546

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that before use of the bd posiflush¿ normal saline syringe the syringe was contaminated with a foreign body floating inside the fluid.

Manufacturer Narrative

H.6.Investigation summary: one sample was received.It has the plunger rod-rubber stopper, tip cap, solution and barrel label.There is a piece of foreign matter floating in the solution.It is about 1/8¿ long.Additional testing confirmed that the solution was normal saline.Additionally, spectral analysis of the foreign matter revealed that the particle was wool.Testing to different materials in the fill room was performed and no matches were found.It is likely that the wool came from clothing.Operator interaction with the product is minimal, however, contamination is possible if proper gowning is not followed.All operators are trained to a gowning procedure to minimize risk of contamination.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# 8292600 for the same defect or symptom.There was no documentation of issues for the complaint of batch #8292600 during the production run.

Event Description

It was reported that before use of the bd posiflush¿ normal saline syringe the syringe was contaminated with a foreign body floating inside the fluid.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8403979
• MDR Text Key: 138813644
• Report Number: 1911916-2019-00253
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

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: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 306546
• Device Lot Number: 8292600
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other