MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY 5 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; PRE-FILLED SYRINGE

Catalog Number 306574

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.This is the 1st complaint for the lot# 8201714 for the same defect or symptom.There was no documentation of issues for the complaint of batch #8201714 during the production run.Root cause description: undetermined.

Event Description

It was reported that a 5 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9% was dirty on the adapter.

Manufacturer Narrative

The correction is as follows: date received by manufacturer: 2019-02-19.

Event Description

It was reported that a 5 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9% was dirty on the adapter.

• Brand Name: 5 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PRE-FILLED SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8368358
• MDR Text Key: 137527236
• Report Number: 1911916-2019-00219
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065745
• UDI-Public: 382903065745
• 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: 02/28/2019

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: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 306574
• Device Lot Number: 8201714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other