BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500

    MDR report key: 12546572 · Received September 29, 2021

    Report

    Report Number
    1920898-2021-01019
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    August 30, 2021
    Report Date
    September 10, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9112701, MEDICAL DEVICE EXPIRATION DATE: 04/30/2024, DEVICE MANUFACTURE DATE: 04/22/2019. MEDICAL DEVICE LOT #: 9112698, MEDICAL DEVICE EXPIRATION DATE: 05/31/2024, DEVICE MANUFACTURE DATE: 04/22/2019. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED FOR THE PROVIDED MATERIAL NUMBER AND LOT NUMBERS, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO SYRINGE 0.3ML 31G 8MM WHOLE UNIT 10BG 500 HAD MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REQUESTED INFORMATION ON EXPIRATION DATE, SAID HE PURCHASED THE SYRINGES IN 2019 BUT COULD NOT LOCATE AN EXPIRATION DATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445417 SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 SEE H.10. 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1