BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 12100588 · Received July 1, 2021

    Report

    Report Number
    1920898-2021-00715
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 3, 2021
    Report Date
    June 9, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THE CUSTOMER'S ADDRESS IS UNKNOWN:  (B)(6), USA HAS BEEN USED AS A DEFAULT.  THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 3043392, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2013-03-25. MEDICAL DEVICE LOT #: 2339296, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2013-01-24. 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 EACH OF THE REPORTED LOT NUMBERS. 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. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR LABEL INFORMATION MISSING (EXPIRATION DATE) ON LOT # 3043392. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR LABEL INFORMATION MISSING (EXPIRATION DATE) ON LOT # 2339296. DUE TO THIS BATCH BEING MANUFACTURED IN 2013 AND FILES ARE RETAINED FOR 7 YEARS NO DHR REVIEW CAN BE COMPLETED. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT LEAST 2 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLES EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:328466 BATCH NO: 3043392, 2339296. CONSUMER REQUESTED EXPIRATION DATE ON SYRINGES, STATED THAT THERE WAS NO EXPIRATION DATE ON THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001258 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328466 SEE H10 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1