MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA

Catalog Number 301948

Device Problem Fungus in Device Environment (2316)

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

Event Date 05/07/2019

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 the syringe s2 20ml 18ga 1-1/2in bd (b)(4) experienced mold presence.The following information was provided by the initial reporter: before use, it was found black foreign matter on plunger, like mold.

Manufacturer Narrative

H.6.Investigation: bd was provided with a photo and samples for catalog 301948 lot 1811364 to investigate the record.The analysis of the sample showed small black particles in the body of the syringe, outside the fluid path.As a result, bd was able to verify the reported issue.Bd has determined that the foreign matter of the non-conformance consists of very small piece of dust mixed with the silicone of the syringe.The silicone oil is used to lubricate the inner part of the barrel and facilitate the movement of the plunger rod.The dust in this case came from the hopper of the assembly machine.In that case, bd considers that because of a punctual failure in the cleaning procedures by the operator, the presence of this particulates in the hopper was not correctly avoided manufacturing.

Event Description

It was reported that the syringe s2 20ml 18ga 1-1/2in bd china experienced mold presence.The following information was provided by the initial reporter: before use, it was found black foreign matter on plunger, like mold.

• Brand Name: SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8617489
• MDR Text Key: 146512293
• Report Number: 3002682307-2019-00314
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• 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: 301948
• Device Lot Number: 1811364
• Date Manufacturer Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other