MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ SYRINGE WITH BD LUER-LOK¿ TIP; CONVENTIONAL SYRINGE

Catalog Number 309653

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/23/2018

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 before use a bd¿ syringe with bd luer-lok¿ was found with foreign matter as ¿the syringe plunger was contaminated.¿ there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

A sample was available to bd for evaluation.There was foreign matter embedded into the plastic of the plunger rod thus verifying the reported issue.Foreign matter can become embedded into the plastic of syringes during the start-up of the molding process.This happens when solidified resin within the mold and molding press becomes discolored or degraded once heated.The press is supposed to be placed into start up and ran until any potential foreign matter gets flushed through the system is no longer detected but sometimes a piece is missed and gets molded into a syringe.A device history review was performed on the reported lot and found zero issues noted during production.Embedded fm can occur at the startup of the injection molding process.Solidified resin within the mold and molding press may become discolored or degraded when reheated.

• Brand Name: BD¿ SYRINGE WITH BD LUER-LOK¿ TIP
• Type of Device: CONVENTIONAL SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7331208
• MDR Text Key: 102220241
• Report Number: 1911916-2018-00104
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096535
• UDI-Public: 30382903096535
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 309653
• Device Lot Number: 7326542
• Date Manufacturer Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other