MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ LUER LOK SYRINGE

Catalog Number 301035

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

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 bd¿ luer lok syringe had foreign matter inside the plunger.

Manufacturer Narrative

B.5.Describe event or problem: it was reported that bd¿ luer lok syringe had foreign matter inside the plunger.It was reported that 155 devices were affected.H.6.Investigation summary: 12 samples were received for evaluation.4 samples have no defects noted.2 had black specs on the barrel wall and one on the plunger rod.5 had burnt plastic on the barrel flange.Failure mode is verified.Embedded foreign matter can occur at the startup of an injection mold/press or intermittently during the injection molding process.Degraded resin inherently builds up in the barrel and hot-runner system of the mold and press.The degraded resin can break loose and be molded into components.This is a cosmetic defect only and does not affect the integrity of the syringe.Burns can be caused when there is blockage in the mold vents/ gates which can cause burns on the flange of the syringe during molding process.Syringes with these conditions are safe for use as intended and the defect rate is acceptable per product specification.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

Event Description

It was reported that bd¿ luer lok syringe had foreign matter inside the plunger.It was reported that 155 devices were affected.

• Brand Name: BD¿ LUER LOK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8190860
• MDR Text Key: 131306390
• Report Number: 1911916-2018-00766
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 301035
• Device Lot Number: 7179903
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other