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

Catalog Number 301947

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd¿ syringe with needle had foreign matter in the barrel.The following information was provided by the initial reporter: before using, it was found that the end of barrel with black foreign matter.

Event Description

It was reported that bd¿ syringe with needle had foreign matter in the barrel.The following information was provided by the initial reporter: before using, it was found that the end of barrel with black foreign matter.

Manufacturer Narrative

Investigation: bd has been provided with a photo for catalog 301947 lot 1810136 to investigate for this record.Bd was able to see an insect allocated in the external part of the barrel, verifying the reported issue.Based on the feedback provided, the insect could be introduced in the syringe during storage after production or during production in the assembly room ending at the primary packaging machine.The most probable root cause is that this issue happened during the transport of material during assembly.Dhr showed no indication of the alleged defect.

• Brand Name: BD SYRINGE WITH NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8573394
• MDR Text Key: 144979324
• Report Number: 3002682307-2019-00284
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903019472
• UDI-Public: 382903019472
• 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: 05/30/2019

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 301947
• Device Lot Number: 1810136
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 04/17/2019
• Supplement Dates FDA Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other