MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD 20ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Model Number 302830

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/05/2019

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 foreign matter occurred before use with a bd 20ml syringe luer-lok¿ tip.The following information was provided by the initial reporter, "syringe has two brown spots on luer lok area, one brown spot on syringe barrel, and two brown spots at the bottom of the barrel.".

Manufacturer Narrative

H.6.Investigation: one (1) sample was provided by the customer for investigation.The sample was visually examined using unaided vision and was observed to have brown foreign matter embedded in the syringe barrel in two (2) locations on the luer lok® collar, one (1) location in the syringe barrel and two (2) locations in the syringe flange.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.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 foreign matter occurred before use with a bd 20ml syringe luer-lok¿ tip.The following information was provided by the initial reporter, "syringe has two brown spots on luer lok area, one brown spot on syringe barrel, and two brown spots at the bottom of the barrel.".

• Brand Name: BD 20ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 9525467
• MDR Text Key: 193914652
• Report Number: 1911916-2019-01336
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028307
• UDI-Public: 30382903028307
• 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
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 302830
• Device Catalogue Number: 302830
• Device Lot Number: 9240621
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other