MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%

Catalog Number 306575

Device Problem Leak/Splash (1354)

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

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one sample was received.It has opened packaging flow wrap.It has the plunger rod-rubber stopper, the tip cap, saline solution.The luer tip is bent.This occurs when the syringe is misplaced in the sterilizer tray.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.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 1st complaint for lot # 9227890 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: this occurs when the syringe is misplaced in the sterilizer tray.

Event Description

It was reported that a bent syringe was found before use with a 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter, "when the outer plastic was removed from the 10ml normal saline syringe flush, it was noticed by the rn that the syringe was disfigured.The top of the syringe was bent out of shape.".

• Brand Name: 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• 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 ; 8015652341
• MDR Report Key: 9456085
• MDR Text Key: 194204871
• Report Number: 1911916-2019-01304
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/04/2019

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: 08/31/2022
• Device Catalogue Number: 306575
• Device Lot Number: 9227890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other