BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS

    MDR report key: 10941261 · Received December 3, 2020

    Report

    Report Number
    1920898-2020-01667
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 9, 2020
    Report Date
    January 19, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 12/4/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 1/2CC, 8MM SYRINGE. CUSTOMER STATES THAT THE NEEDLE WOULD NOT DRAW UP INSULIN. THE RETURNED SYRINGE WAS TESTED AND WAS ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0083438. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200885154, 200884684, 200884660] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS WOULD NOT ASPIRATE AND THE PLUNGER WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:328468 BATCH NO: 0083438, UNKNOWN. IT WAS REPORTED THAT THE NEEDLE WOULD NOT DRAW UP INSULIN. ALSO, THE PLUNGER WOULD NOT STAY IN THE SYRINGE AND A SYRINGE DID NOT HAVE A NEEDLE. VERBATIM: CONSUMER REPORTED WHEN TRYING TO DRAW UP INSULIN THE NEEDLE WOULD NOT DRAW IT UP, NO INSULIN WAS GOING INTO THE SYRINGE. STATED IF SHE HAD INJECTED HERSELF SHE WOULD HAVE PUT AIR INTO HER VEINS. STATED SHE HAD A DIFFERENT BOX IN THE PAST WHERE THE PLUNGER WOULD NOT STAY IN THE SYRINGE. STATED ONE SYRINGE ALSO DIDN'T HAVE A NEEDLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 0083438; MEDICAL DEVICE EXPIRATION DATE: 2025-04-30; DEVICE MANUFACTURE DATE: 2020-03-23. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS WOULD NOT ASPIRATE AND THE PLUNGER WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:328468 BATCH NO: 0083438, UNKNOWN. IT WAS REPORTED THAT THE NEEDLE WOULD NOT DRAW UP INSULIN. ALSO, THE PLUNGER WOULD NOT STAY IN THE SYRINGE AND A SYRINGE DID NOT HAVE A NEEDLE. VERBATIM: CONSUMER REPORTED WHEN TRYING TO DRAW UP INSULIN THE NEEDLE WOULD NOT DRAW IT UP, NO INSULIN WAS GOING INTO THE SYRINGE. STATED IF SHE HAD INJECTED HERSELF SHE WOULD HAVE PUT AIR INTO HER VEINS. STATED SHE HAD A DIFFERENT BOX IN THE PAST WHERE THE PLUNGER WOULD NOT STAY IN THE SYRINGE. STATED ONE SYRINGE ALSO DIDN'T HAVE A NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408157 SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328468 SEE H.10 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1