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

Catalog Number 301229

Device Problem Component Misassembled (4004)

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

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

(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 the stopper had been "incorrectly lodged" in the bd plastipak¿ luer-lock syringe.

Event Description

It was reported that the stopper had been "incorrectly lodged" in the bd plastipak¿ luer-lock syringe.

Manufacturer Narrative

Investigation: two sample units belonging to lot number 1803271 were received for evaluation by our quality engineer.Through visual inspection of the samples, the stopper was observed wrongly assembled and it was distorted against the barrel walls.A device history record review was completed for the provided lot number.The review did reveal one non-conformance during the production of lot number 1803271 that could have contributed to this incident.During the assembly process, a failure was detected in the assembly station which was resulting in incorrectly assembled stoppers.Once the failure was detected, defective samples were rejected and the mechanical team repaired the failure.It is possible that the product involved in this incident was manufactured prior to the detection of this failure or it was not properly rejected.

Event Description

It was reported that the stopper had been "incorrectly lodged" in the bd plastipak¿ luer-lock syringe.

Manufacturer Narrative

Investigation summary: no sample nor picture has been received for investigation.A device history record review was completed for the provided lot number.The review did reveal one non-conformance during the production of lot number 1803271 that could have contributed to this incident.During the assembly process, a failure was detected in the assembly station which was resulting in incorrectly assembled stoppers.Once the failure was detected, defective samples were rejected and the mechanical team repaired the failure.It is possible that the product involved in this incident was manufactured prior to the detection of this failure or it was not properly rejected.A project has been opened to install a vision system within the assembly station that will monitor for this defect.According to inspection plan procedure jg-500, 200 units are inspected every 2 pallets by quality control team.In addition, final products in this manufacturing line, for this reference and lot size are sampled by operator and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures (jg-301, jg-302, jg-303 and jg-304): 1.Visual inspection molding: 2 injections per shift.Printing: 10 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Assembly: 10 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.2.Functional inspection printing: once in pallet#1, once in pallet#7, once in pallet#14 and once in pallet#22.Assembly: once in pallet#1, once in pallet#7, once in pallet#14 and once in pallet#22.Primary packaging: once in pallet#1, once in pallet#7, once in pallet#14 and once in pallet#22.We can confirm that the root cause of the non-conformance is related with the failure detected during manufacturing process in the assembly station.Project#1688 has been opened to install a vision system in the assembly station to defect this defect.

• Brand Name: BD PLASTIPAK¿ LUER-LOCK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8203000
• MDR Text Key: 131764087
• Report Number: 3003152976-2018-00564
• 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,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 301229
• Device Lot Number: 1803271
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other