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

Catalog Number 306594

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

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

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: two photos were provided.One photo show two syringes.Both are with no packaging flow wrap, do not have tip cap nor saline solution.One sample has the plunger rod-rubber stopper all the way down.The other syringe has the plunger rod-rubber stopper all the way up which has already over the retention ring, this position is not how it the syringe is produced.The other photo shows the same syringes of the first photo, the difference is that the syringe that had the plunger rod-rubber stopper all the way up, now has been removed and are next to the barrel.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.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: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure from the photos provided.This is the 1st complaint for lot # 9206013 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: based on the photo samples the root cause could not be determined.Rationale: capa not required at this time.

Event Description

It was reported that the bd posiflush¿ syringe plunger could not be pushed in halfway during the injection.This occurred on 6 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter, translated from chinese to english: "the flush (5ml) could not be pushed to the halfway of the barrel during the injection.".

• Brand Name: BD POSIFLUSH¿ SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10003520
• MDR Text Key: 189458806
• Report Number: 1911916-2020-00415
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 306594
• Device Lot Number: 9206013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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