BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN

    MDR report key: 11228286 · Received January 25, 2021

    Report

    Report Number
    1920898-2021-00107
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    January 4, 2021
    Report Date
    March 12, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282913
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-02-09. INVESTIGATION SUMMARY: CUSTOMER RETURNED (B)(4) LOOSE 3/10CC SYRINGE. CUSTOMER STATES THAT THE SHIELDS WERE DIFFICULT TO REMOVE AND THE NEEDLE HUB SEPARATED. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9161979 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN WHEN REMOVING SHIELD THE HUB SEPARATED FROM DEVICE. THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE HUB SEPARATED AND SHIELDS WERE DIFFICULT TO REMOVE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN WHEN REMOVING SHIELD THE HUB SEPARATED FROM DEVICE. THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE HUB SEPARATED AND SHIELDS WERE DIFFICULT TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121354 BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328291 9161979 00382903282913

    Patients

    Seq Age Sex Outcome Treatment
    1