MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRASAFE PASSIVE¿ X50 NEEDLE GUARD SYRINGE; SAFETY SYRINGE

Catalog Number 47475802

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(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 that there were eight plunger rods for bd ultrasafe passive¿ x50 needle guard syringe that were found with "barbs".There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: no samples were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.However, a photograph provided by the customer confirms the reported failure this batch was manufactured by a moulding supplier.Bdm-ps performed a review of the release documents and the batch met all acceptable quality levels (aql¿s), was manufactured and released according to applicable procedures and specifications.The samples provided show varying degrees of flash and originate from different cavity numbers.Flash is a result of molten material penetrating beyond the ends of the cavity.An initial investigation conducted by the supplier indicated that the flash was caused by double shots due to the machine clamp sensors not working properly.A supplier complaint (b)(4) was raised with the supplier on receipt of a previous complaint of this nature.It was found that the sensors were worn out.However the sensors were repaired and as a preventive action the supplier has introduced preventive maintenance which is effective from (b)(6) 2018.The affected batch was manufactured prior to the previous complaint (b)(4) which initiated supplier complaint (b)(4) and the subsequent corrective and preventative actions.

Event Description

It was reported that there were eight plunger rods for bd ultrasafe passive¿ x50 needle guard syringe that were found with "barbs".There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD ULTRASAFE PASSIVE¿ X50 NEEDLE GUARD SYRINGE
• Type of Device: SAFETY SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; faraday road; dorcan; swindon wiltshire SN3 5 JH; UK SN3 5JH
• MDR Report Key: 7874810
• MDR Text Key: 120389319
• Report Number: 3001741852-2018-00016
• Device Sequence Number: 1
• Product Code: FMF
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

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: 12/29/2021
• Device Catalogue Number: 47475802
• Device Lot Number: 1737451
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 08/23/2018
• Supplement Dates FDA Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other