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

Catalog Number 309653

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/26/2019

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.The customer's address is unknown:  (b)(6) has been used as a default.

Event Description

It was reported that foreign matter occurred with a bd 60ml syringe luer-lok¿ tip.The following information was provided by the initial reporter."material no.309653, batch no.8303990.It was reported there is foreign matter in the syringe."i have another quality report.A 60cc syringe was sent to me with what appears to be dirt in the sealed packaging.Ref: (b)(4), lot: 8303990".

Manufacturer Narrative

H.6.Investigation: one (1) photo was provided by the customer.It shows the end of a syringe in a blister pack.There appears to be black foreign matter (fm) in or on the packaging.Additionally, a sample was received.There is black foreign matter (fm) sealed inside the packaging.The foreign matter (fm) was identified as grease.Grease likely got on the plunger rod during the molding process.If the plunger rod would come in contact with the areas outside of the mold face and the good product chute, it could potentially come in contact with grease on the press.There is part containment in place to try and mitigate the issue, but due to static on the mold face the plunger rods can sometimes land in unpredictable locations.These parts can potentially fall back into the chute due to the vibration of the press.A device history record review was completed with zero defects found relating to foreign matter.No quality notifications were written for this batch, nor for the associated assembly batches.

Event Description

It was reported that foreign matter occurred with a bd 60ml syringe luer-lok¿ tip.The following information was provided by the initial reporter: "material no.309653.Batch no.8303990.It was reported there is foreign matter in the syringe."i have another quality report.A 60cc syringe was sent to me with what appears to be dirt in the sealed packaging.Ref: 309653.Lot: 8303990.".

• 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: 8510150
• MDR Text Key: 142478826
• Report Number: 1911916-2019-00376
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 309653
• Device Lot Number: 8303990
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other