MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE

Catalog Number 306546

Device Problems Material Discolored (1170); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: two (2) samples were received for evaluation.The tip cap of each sample has black discoloration, therefore failure mode is verified.After opening the packaging flow wrap the tip caps were inspected finding embedded black discoloration.This tip cap discoloration was induced during the molding process of the tip caps.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: this is the first complaint for the lot# 8242589 for the same defect or symptom.There was no documentation of issues for the complaint of batch 8242589 during this production run.Root cause description: this tip cap discoloration was induced during the molding process of the tip caps.

Event Description

It was reported that 10 ml bd posiflush¿ normal saline syringe had black discoloration on the tip of the syringe.This occurred on 2 separate occasions but the date/time and or patient information is unknown.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 8279707
• MDR Text Key: 134242858
• Report Number: 1911916-2019-00115
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• 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: 8242589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2018
• 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