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

Catalog Number 306546

Device Problems Crack (1135); Melted (1385); Material Twisted/Bent (2981); Sharp Edges (4013)

Patient Problem No Information (3190)

Event Date 01/16/2019

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 a bd posiflush normal saline syringe was bent, melted, sharp, and partially cracked upon opening the package.

Manufacturer Narrative

Investigation summary: one sample was received for evaluation.This is the first complaint for the lot# 8242677 for the same defect or symptom.There was no documentation of issues for the complaint of batch #8242677 during this production run.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: the luer tip is damaged/ deformed therefore failure mode is verified.No other damages were observed on the barrel, plunger rod or tip cap.Root cause description: if the tip cap cup somehow has a piece of plastic from a tip cap jam, then that piece will induce the damage to the luer.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 a bd posiflush¿ normal saline syringe was bent, melted, sharp, and partially cracked upon opening the package.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: VASCULAR CATHETER FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8283799
• MDR Text Key: 134363060
• Report Number: 1911916-2019-00126
• 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: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• 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: 306546
• Device Lot Number: 8242677
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other