MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL; PISTON SYRINGE

Model Number 328512

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

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.(b)(4).

Event Description

It was reported that a syringe 0.3ml 31ga 8mm 10bag 500 wal separated from the hub during use.The following was reported by the initial reporter: "it was reported by the consumer that the needle hub separated and stayed inside of the shield.Verbatim: consumer reported needle hub separated and stayed inside of the shield.".

Manufacturer Narrative

H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch # 0098920 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200886538] noted that did not pertain the complaint.

Event Description

It was reported that a syringe 0.3ml 31ga 8mm 10bag 500 wal separated from the hub during use.The following was reported by the initial reporter: "it was reported by the consumer that the needle hub separated and stayed inside of the shield.Verbatim: consumer reported needle hub separated and stayed inside of the shield.".

• Brand Name: SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11103504
• MDR Text Key: 226073327
• Report Number: 1920898-2020-01786
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311786
• UDI-Public: 00681131311786
• 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,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328512
• Device Catalogue Number: 328512
• Device Lot Number: 0098920
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1