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

Catalog Number 306575

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 12/13/2018

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 with the use of the bd posiflush¿ sp syringe there was an issue with plunger stuck within the barrel and could not be pushed.

Manufacturer Narrative

Investigation summary: one sample was received for evaluation.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# 8223659 for the same defect or symptom.There was no documentation of issues for the complaint of batch 8223659 during this production run.Investigation conclusion: the breakout force was at 15.35n and the sustaining force at 9.15n.Product specifications: breakout force<40n, sustaining force<20n.The sample is within product specification therefore failure mode is not verified.Root cause description: no root cause can be determined.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 with the use of the bd posiflush¿ sp syringe there was an issue with plunger stuck within the barrel and could not be pushed.

• Brand Name: BD POSIFLUSH¿ SP SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8203107
• MDR Text Key: 131704955
• Report Number: 1911916-2018-00798
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 306575
• Device Lot Number: 8223659
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other