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

Catalog Number 306595

Device Problem Material Separation (1562)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd posiflush¿ normal saline syringe stopper separated from plunger during use.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: one sample was received for evaluation.It has no packaging flow wrap, no tip cap and no solution.The plunger rod-rubber stopper is at the 8.5ml mark.The plunger rod is assembled to the rubber stopper.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 first complaint for the lot# 8019840 for the same defect or symptom.There was no documentation of issues for the complaint of batch 8019840 during this production run.Investigation conclusion: the plunger rod and the rubber stopper were removed to measure the separation between both.The separation is 3/64¿.The product specification is <1/16¿.The sample is within product specification therefore failure mode is not verified.Root cause description: the sample is within product specification therefore failure mode is not verified.Rationale: 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.

Event Description

It was reported that bd posiflush¿ normal saline syringe stopper separated from plunger during use.No serious injury or medical intervention was reported.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8189931
• MDR Text Key: 131177041
• Report Number: 1911916-2018-00772
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K982558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

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: 01/31/2021
• Device Catalogue Number: 306595
• Device Lot Number: 8019840
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other