MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS; PISTON SYRINGE

Model Number	328431
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that a syringe 0.3ml 30ga 1/2in uf 10bag 500cs separated from the hub during use.The following was reported by the initial reporter: "it was reported that when needle shield was removed the needle hub separated into it.Verbatim: pet owner reported, when she removed needle shield, needle hub separated 1 syringe affected".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-05-24.H6: investigation summary: ustomer returned a single syringe in a pouch labeled for 0.3ml, 30 gauge, 12.7mm syringes from lot 0111971.The syringe was returned intact.The sample received shield pull force testing.The pull force required to remove the needle shield was 2.61 lbs.The specification states that all pull forces within the range of 0.85 lbs to 5.95 lbs are acceptable.This syringe tested within the required range and did not disassemble during testing.No defects or other damage observed.A review of the device history record was completed for batch# 0111971.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that pertained to the complaint.Based on the sample received, bd was unable to replicate or confirm the customer¿s indicated failure of needle hub separation.H3 other text : see h10.
Event or Problem Description
It was reported that a syringe 0.3ml 30ga 1/2in uf 10bag 500cs separated from the hub during use.The following was reported by the initial reporter: "it was reported that when needle shield was removed the needle hub separated into it.Verbatim: pet owner reported, when she removed needle shield, needle hub separated 1 syringe affected".

• Brand Name: SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11809586
• Report Number: 1920898-2021-00541
• Device Sequence Number: 14336549
• Product Code: FMF
• UDI-Device Identifier: 00382908431033
• UDI-Public: 00382908431033
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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: 04/30/2025
• Device Model Number: 328431
• Device Catalogue Number: 328431
• Device Lot Number: 0111971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1