MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL; SYRINGE, PISTON

Model Number	328512
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : not available.
Event or Problem Description
Consumer reported reusing syringe 4 times a day for 4 days.This same syringe broke off in right upper thigh in last nights injection.Can't find/see it in her site.Nor on the floor.Informed caller reasons not to reuse.She has not seen medical attention as of yet.Not sure if she will.- dc lot # 3191935 catalog# 328512 date of event december 17, 2023 sample status discard (b)(4).
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
• Manufacturer (Section G): BECTON DICKNSON; 1 becton drive; franklin lakes, 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18488618
• Report Number: 1920898-2024-05004
• Device Sequence Number: 3533517
• Product Code: FMF
• UDI-Device Identifier: 00681131311786
• UDI-Public: (01)00681131311786
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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
• Device Model Number: 328512
• Device Lot Number: 3191935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female