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

Catalog Number 306499

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: five samples were received.One sample has 7.5ml of blood in it and the plunger is out of the syringe.Another sample has 1.5ml of blood and the plunger rod is out of the syringe.There are other three samples with the plunger rod assembled: two have the plunger rod- rubber stopper all the way down and no tip cap; the other has the plunger rod-rubber stopper at 5ml it has the tip cap and a solution in it.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.Investigation conclusion: confirmed: bd was able to duplicate or confirm the customer's indicated failure mode with the samples provided.This is the 3rd complaint for the lot# 8348869 for the same defect or symptom.Previous complaint (b)(4).There was no documentation of issues for the complaint of batch 8348869 during the production run.Root cause description: failure mode is verified, however, the posiflush product is designed to flush the iv lines, not for drawing blood.This would be considered off label use.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 the stopper separated from the plunger in the bd posiflush¿ sf saline syringe during the aspiration.The following information was provided by the initial reporter: "the plunger is coming ¿unscrewed¿ and they screw it back and it sometimes works and other times pops back off when aspirating.".

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8716475
• MDR Text Key: 149226075
• Report Number: 1911916-2019-00608
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903064991
• UDI-Public: 00382903064991
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 306499
• Device Lot Number: 8348869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other