BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE INSULIN SYRINGE

    MDR report key: 9202445 · Received October 17, 2019

    Report

    Report Number
    1920898-2019-01156
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    September 3, 2019
    Report Date
    November 19, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 18 NOVEMBER 2019 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. CANNOT PERFORM A DHR REVIEW DUE TO AN UNKNOWN LOT NUMBER. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ INSULIN SYRINGE NEEDLE BROKE OFF IN THE PATIENT'S LEFT THIGH DURING USE AND HAD TO BE SURGICALLY REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "2 X BROKEN OFF INSULIN NEEDLES OF BD 12 MM WITHIN 7 TG 03.09.2019 LEFT THIGH AND 10.09.2019 RIGHT THIGH IN THE MIDDLE, MUST BE REMOVED SURGICALLY."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ INSULIN SYRINGE NEEDLE BROKE OFF IN THE PATIENT'S LEFT THIGH DURING USE AND HAD TO BE SURGICALLY REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "2 X BROKEN OFF INSULIN NEEDLES OF BD 12 MM WITHIN 7 TG (B)(6) 2019 LEFT THIGH AND (B)(6) 2019 RIGHT THIGH IN THE MIDDLE, MUST BE REMOVED SURGICALLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999698 BD MICRO-FINE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention