BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 10440589 · Received August 23, 2020

    Report

    Report Number
    1920898-2020-01100
    Event Type
    Malfunction
    Date Received
    August 23, 2020
    Date of Event
    July 31, 2020
    Report Date
    August 24, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 3/10CC SYRINGE. CUSTOMER STATES THAT WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB. THE RETURNED SYRINGE WAS TESTED AND THE HUB-NEEDLE ASSEMBLY DID NOT SEPARATE FROM THE BARREL WHEN THE SHIELD WAS REMOVED. UNABLE TO PERFORM DHR CHECK FOR NEEDLE HUB SEPARATES DUE TO UNKNOWN LOT NUMBER. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE BD ULTRA-FINE¿ INSULIN SYRINGE. THIS OCCURRED WITH 2 SYRINGES BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB. NO INFORMATION ON WHETHER THE SHIELD WAS TIGHT TO REMOVE OR NOT WAS PROVIDED.".

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE BD ULTRA-FINE¿ INSULIN SYRINGE. THIS OCCURRED WITH 2 SYRINGES BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB. NO INFORMATION ON WHETHER THE SHIELD WAS TIGHT TO REMOVE OR NOT WAS PROVIDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904903 BD ULTRA-FINE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other