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

Model Number 324911

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 syringe 0.5ml 31ga 6mm 10bag 500cs leaked.The following information was provided by the initial reporter: it was reported by the consumer, the syringe leaks near the top of the plunger rod, the needle shield was difficult to remove, the needles bent when the needle shield was removed.

• Brand Name: SYRINGE 0.5ML 31GA 6MM 10BAG 500CS
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12610691
• MDR Text Key: 282109103
• Report Number: 1920898-2021-01067
• 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: consumer,other
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• 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: 1060364
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1