MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SP SYRINGE

Catalog Number 306575

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date:unknown.Initial reporter phone#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd posiflush¿ sp syringe there was an issue with damage/defective/empty packaging.It was stated ¿upon opening the box the syringe wrapping was already torn.The syringe was found taken apart with the saline solution missing.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: a photo was provided to bd for evaluation.A quality engineer was able to review the provided photo and determined that there was a tear in the middle of the packaging.The other half of the packaging had the plunger rod stopper in it.The plunger was next to the barrel with a tip cap.The barrel appeared to be empty.Based off of the photo provided the engineer was able to verify the reported issues.This was most likely caused by a variation with the plunger rod labeler equipment.The equipment was inspected and any adjustments were made and the equipment was verified to be working properly.A review of the device history record could not be performed since there wasn't a lot number provided for this sample.No corrective actions were deemed necessary at this time.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD POSIFLUSH¿ SP SYRINGE
• Type of Device: FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7519666
• MDR Text Key: 108621265
• Report Number: 1911916-2018-00232
• Device Sequence Number: 1
• Product Code: NGT
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

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 Catalogue Number: 306575
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other