BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ SYRINGE ALLERGIST TRAY WITH NEEDLE

    MDR report key: 7423270 · Received April 11, 2018

    Report

    Report Number
    1920898-2018-00195
    Event Type
    Malfunction
    Date Received
    April 11, 2018
    Date of Event
    March 20, 2018
    Report Date
    May 22, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    UDI-DI
    00382903059508
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED 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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #7207988. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE SIX NOTIFICATIONS NOTED FOR SPINNERS. THERE WERE FOUR NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #7171628. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS:  MEDICAL DEVICE LOT #: 7171628, EXPIRATION DATE: 2022-07-31, MANUFACTURE DATE: 2017-06-20. MEDICAL DEVICE LOT #: 7207988, EXPIRATION DATE: 2022-07-31, MANUFACTURE DATE: 2017-07-26. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE ON A BD SAFETYGLIDE¿ SYRINGE ALLERGIST TRAY WITH NEEDLE WAS BENT BACKWARDS RESULTING IN RUBBER STOPPER DAMAGE WHICH COULD LEAD TO LEAKAGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266286 BD SAFETYGLIDE¿ SYRINGE ALLERGIST TRAY WITH NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE MEG BD MEDICAL - DIABETES CARE SEE SECTION H.10. 00382903059508

    Patients

    Seq Age Sex Outcome Treatment
    1 Other