MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE S2

Catalog Number 301942

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 03/22/2019

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 twenty bd¿ syringe s2 had foreign matter on the needle before use.Foreign complaints the following information was provided by the initial reporter, translated from (b)(6) to english: ¿after opening the unit package,a plastic foreign matter in needle hub.20 affected samples in one shelf carton was found".

Manufacturer Narrative

Investigation: bd has been provided with the affected sample for catalog 301942, lot 1802143, to investigate for this record.Visual inspection of the sample revealed a piece of the pin rack in the hub coming from the assembly needle machine.As a result, bd was able to verify the reported issue.In order to move the pieces through the assembling process, the needles are located in some plastic racks made of green polycarbonate.Based on the reported issue, our opinion is that one of these "rack pins" may break because of any blockage in the manufacturing process remaining attached to the needle.Dhr showed no indication of the alleged defect.

Event Description

It was reported that twenty bd¿ syringe s2 had foreign matter on the needle before use.Foreign complaints the following information was provided by the initial reporter, translated from chinese to english: ¿ after opening the unit package, a plastic foreign matter in needle hub.20 affected samples in one shelf carton was found ¿.

• Brand Name: BD SYRINGE S2
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8475934
• MDR Text Key: 145093292
• Report Number: 3002682307-2019-00226
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 301942
• Device Lot Number: 1802143
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other