MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ SYRINGE

Catalog Number 300629

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 during use a bd plastipak¿ syringe malfunctioned as the ¿piston disengaged from the body of a 20 ml syringe after the hcw has done three back and forth movements.There was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: two pictures have been received for investigation.Upon visual inspection of both pictures received it can be observed the stopper is disassembled from plunger in a 20ml ll syringe.Dhr of lot 1711271 has been reviewed not finding any annotation or deviation regarding the alleged defect.Final products in this manufacturing line, for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures: visual inspection -molding: 2 injections per shift.-printing: 18 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.-assembly: 18 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.-primary packaging: 1 advance-step (without product) per two hours, after any intervention in the equipment, and once at the beginning of the shift.-secondary packaging: 1 shelf-package per pallet.Functional inspection -printing: once in the first pallet, once in the middle of the lot and once in last pallet of the lot.-assembly: once in the first pallet, once in the middle of the lot and once in last pallet of the lot.-primary packaging: once in the first pallet, once in the middle of the lot and once in last pallet of the lot.Investigation conclusion: although no issues were identified and manufacturing record stablished that all production and quality processes were carried out normally, we can confirm that the root cause of the non-conformance is related with a mechanical failure in assembly station.This defect has been produced due to a mechanical failure in assembly station during assembly process.Stopper can be wrongly assembled if assembly wheels for plunger-stopper assembly are not correctly aligned or if stopper is not correctly placed previous to assembly to the plunger rod.Since no incidence has been found during manufacturing process of this lot it cannot be determined which of the two options happened.The stopper was completely disassembled from plunger during use.

• Brand Name: BD PLASTIPAK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7359274
• MDR Text Key: 103408150
• Report Number: 3003152976-2018-00124
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 300629
• Device Lot Number: 1711271
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other