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 Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

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.Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.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.Root cause description: undetermined.

Event Description

It was reported that a 5 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9% had no label.

• 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
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8368280
• MDR Text Key: 137517173
• Report Number: 1911916-2019-00218
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065745
• UDI-Public: 382903065745
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2018
• 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