MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 6MM 10BAG 500CS; PISTON SYRINGE

Model Number 324911

Device Problem Failure to Deliver (2338)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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 syringe 0.5ml 31ga 6mm 10bag 500cs needle broke off.This occurred on 2 occasions.The following information was provided by the initial reporter: material no.324911 batch no.Unknown (provided: 7352842).It was reported that needle broke off into skin during injection and was removed from site with tweezers.Verbatim: pharmacist reported complaint on behalf of consumer.Stated during the consumer's injection the needle broke off of the syringe into her skin.Stated the consumer removed the needle from her injection site with tweezers.No injury reported.Stated this happened with two syringes.Consumer declined replacement box from pharmacy at this time.Pharmacist stated consumer does have samples and she will advise the consumer to contact bd.

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch number being unknown, no dhr review can be completed.H3 other text : see h.10.

Event Description

It was reported that syringe 0.5ml 31ga 6mm 10bag 500cs needle broke off.This occurred on 2 occasions.The following information was provided by the initial reporter: material no.324911 batch no.Unknown (provided: 7352842).It was reported that needle broke off into skin during injection and was removed from site with tweezers.Verbatim: pharmacist reported complaint on behalf of consumer.Stated during the consumer's injection the needle broke off of the syringe into her skin.Stated the consumer removed the needle from her injection site with tweezers.No injury reported.Stated this happened with two syringes.Consumer declined replacement box from pharmacy at this time.Pharmacist stated consumer does have samples and she will advise the consumer to contact bd.

• Brand Name: SYRINGE 0.5ML 31GA 6MM 10BAG 500CS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11382477
• MDR Text Key: 251442283
• Report Number: 1920898-2021-00231
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249114
• UDI-Public: 00382903249114
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 324911
• Device Catalogue Number: 324911
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1