MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Medical device expiration date: unknown.The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that unspecified bd¿ syringe needle went through the shield and stuck the consumers finger.The following information was provided by the initial reporter: material no:unknown batch no: unknown.It was reported that the needle came through the cap and stuck the consumer in the finger.Verbatim: sent: monday, (b)(6) 2021 6:44 am - this morning, (b)(6), 2021.The needle came through the cap and stuck me in my finger.I did not even know the needle was strong enough to do that.I sure wish you guys would make that safety cap a bit better.Ouch!!!.

Manufacturer Narrative

H.6.Investigation: no samples were returned therefore the investigation was performed based on the photos provided.Two photos of a u40 bd insulin syringe were provided.The customer reported that the needle came through the cap and stuck them in their finger.The photos were examined, and it was observed that the cannula was through the shield.The exposed cannula could have lead to a needle stick.Due to the batch being unknown, no dhr review can be completed.Root cause cannot be determined.

Event Description

It was reported that unspecified bd¿ syringe needle went through the shield and stuck the consumers finger.The following information was provided by the initial reporter: material no:unknown batch no: unknown.It was reported that the needle came through the cap and stuck the consumer in the finger.Verbatim: sent: monday, (b)(6) 2021 6:44 am - this morning, (b)(6) 2021."the needle came through the cap and stuck me in my finger.I did not even know the needle was strong enough to do that.I sure wish you guys would make that safety cap a bit better.Ouch!!!".

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11355800
• MDR Text Key: 233303017
• Report Number: 2243072-2021-00475
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1