MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928852
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary : exec summary - no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Capa/sa - as no samples were returned for investigation it was determined that no corrective action is required at this time.Dhr review - a review of the device history record was completed for batch# 0125318.All inspections and challenges were performed per the applicable operations qc specifications.
Event or Problem Description
It was reported that 1 bd insulin syringes 0.3ml 29ga 1/2in separated from the hub during use.The following information was provided by the initial reporter : material no.928852; batch no.0125318.It was reported that syringe needles are bent when shield is removed.Also reported needle hub separated into the shield.From the verbatim : consumer found 1 syringe when shield removed the needle hub assembly went off syringe with the shield.Consumer found the needles were bent when removed needle shield.Date of event : (b)(6) 2021 samples status : discarded.

• Brand Name: SYRINGE 0.3ML 29GA 1/2IN 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11817115
• Report Number: 1920898-2021-00546
• Device Sequence Number: 19774670
• Product Code: FMF
• UDI-Device Identifier: 00311917014920
• UDI-Public: (01)00311917014920
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K941657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2025
• Device Model Number: 928852
• Device Catalogue Number: 928852
• Device Lot Number: 0125318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1