MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD 60ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Model Number 309653

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

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

Event Date 12/04/2019

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 was found before use with a bd 60ml syringe luer-lok¿ tip.The following information was provided by the initial reporter, "i would like to report a 60ml bd syringe that had what looks like a staple and something else attached to the luer lock area.".

Manufacturer Narrative

H.6.Investigation summary: one sample and three photos were provided by the customer for investigation.The sample was visually examined using unaided vision and it was observed that there is a piece of metal hooked in the tip of the syringe which has been folded over with other foreign matter caught in the metal piece.The piece of metal examined using 10x magnification by a quality control representative who observed pieces of white rubber in the material which was in the folded piece of metal.This indicated that the piece of metal was likely a tooth which connects two ends of a rubber conveyor which is used to move the assembled syringes during the production process.Three photos were also provided by the customer for investigation.The three photos show the tip of the syringe with the metal piece hooked in the tip from different angles and using different magnifications.It appears that a jam of syringe barrels occurred during the packaging of the batch which resulted in a conveyor belt tooth catching the tip of a syringe barrel and getting hooked in the tip which resulted in the tooth getting ripped out of the conveyor belt.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.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 was found before use with a bd 60ml syringe luer-lok¿ tip.The following information was provided by the initial reporter, "i would like to report a 60ml bd syringe that had what looks like a staple and something else attached to the luer lock area.".

• Brand Name: BD 60ML 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: 9525712
• MDR Text Key: 193667347
• Report Number: 1911916-2019-01337
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309653
• Device Catalogue Number: 309653
• Device Lot Number: 9182726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other