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

Catalog Number 301229

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that the black portion of the plunger was loose on a bd plastipak¿ luer-lock syringe.No serious injury or medical intervention was reported.

Event Description

It was reported that the black portion of the plunger was loose on a bd plastipak¿ luer-lock syringe.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: one physical sample and one picture sample were received for evaluation by our quality engineer team.Upon visual inspection of the samples, the stopper was observed to be incorrectly assembled and partially detached from the plunger.A device history record review did not reveal any documented issues during the production of the provided lot number that could have contributed to the observed/reported defect.The observed defect has been caused by a misalignment during the assembly process.There is a photo-cell in the assembly station to detect improper stopper assembly, however, this incident went undetected.The reason for the lack of detection and the misalignment could not be determined.Investigation conclusion: although no issues were identified and manufacturing record established 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 misalignment of plunger-stopper-barrel in the assembly station.

• Brand Name: BD PLASTIPAK¿ LUER-LOCK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7842392
• MDR Text Key: 119498154
• Report Number: 3003152976-2018-00383
• 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: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 301229
• Device Lot Number: 1804213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other