BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7692929 · Received July 17, 2018

    Report

    Report Number
    1920898-2018-00504
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 21, 2018
    Report Date
    August 14, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249121
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6172775. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR SHIELD LOOSE ON LOT # 6172775. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: SEX: FEMALE. EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO. THIS SUPPLEMENTAL MDR ALSO CORRECTS THE EVENT DESCRIPTION: IT WAS REPORTED THAT THE SHIED ON THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD COME OFF AND WAS LOOSE RESULTING IN A STERILE BREACH. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD STERILE BREACH. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHIED ON THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD COME OFF AND WAS LOOSE RESULTING IN A STERILE BREACH. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. 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 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD STERILE BREACH. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535206 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 6172775 00382903249121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other