BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 10543412 · Received September 16, 2020

    Report

    Report Number
    1920898-2020-01234
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    August 26, 2020
    Report Date
    August 28, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE (1) LOOSE 29GX12.7MM, 0.3ML BD INSULIN SYRINGE. THE CUSTOMER REPORTED THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS ATTACHED TO THE SYRINGE BARREL PROPERLY; REMOVING THE CANNULA SHIELD DID NOT RESULT IN HUB SEPARATION. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECTS WERE OBSERVED THE ALLEGED ISSUE COULD NOT BE CONFIRMED. UNABLE TO PERFORM A DHR REVIEW FOR NEEDLE HUB SEPARATES DUE TO UNKNOWN LOT NUMBER. CONCLUSION: 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. ROOT CAUSE: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE BD ULTRA-FINE¿ INSULIN SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009151 BD ULTRA-FINE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other