MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH SYRINGE; PRE-FILLED SYRINGE

Catalog Number 306594

Device Problem Unsealed Device Packaging (1444)

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

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: three photos were provided.They show a shelf box with the side flap partially out.Another photo shows a person pulling the side flap out.The shelf box is not fully closed.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: confirmed: bd was able to duplicate or confirm the customer's indicated failure mode with the photos provided.This is the 1st complaint for lot # 8141906 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 could have been caused during the shelf box packaging process.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the bd posiflush¿ syringe packaging wasn't tightly sealed and the product fell out easily.The following information was provided by the initial reporter, translated from (b)(6) to english: "the packaging is not tightly sealed, the products are easy to fall out when taking".

• Brand Name: BD POSIFLUSH SYRINGE
• Type of Device: PRE-FILLED SYRINGE
• 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: 8610111
• MDR Text Key: 145113873
• Report Number: 1911916-2019-00470
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 306594
• Device Lot Number: 8141906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2018
• 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