MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 30ML LUER-LOCK SYRINGE

Catalog Number 301229

Device Problem Difficult to Advance (2920)

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

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that a bd plastipak¿ 30ml luer-lock syringe has difficult plunger movement, during use.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: two unused samples were received for evaluation by our quality engineer.Upon visual inspection of the two samples, no damages or molding defects could be observed that would contribute to the alleged defect.A device history record review of lot 1612258p did not reveal any anomalies during the production of the provided lot number that could have contributed to difficult plunger movement.During the manufacturing process break out force, sustaining force, and silicone content tests are performed to ensure that all products are within specification.Break out force, sustaining force, and silicone content tests were performed on ten retained sampled of the same lot number as reported.All test results were within specification.As no issues were identified during the manufacturing process that could have contributed to the reported defect, a definite cause for this incident could not be determined.We can confirm that the root cause of the non-conformance is not related to a manufacturing defect.Based on severity and occurrence no formal capa is required according to internal procedure.

• Brand Name: BD PLASTIPAK¿ 30ML 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: 7599106
• MDR Text Key: 111447613
• Report Number: 3003152976-2018-00239
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 301229
• Device Lot Number: 1612258P
• Date Manufacturer Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other