BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ SYRINGES

    MDR report key: 7778221 · Received August 13, 2018

    Report

    Report Number
    1920898-2018-00599
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 25, 2018
    Report Date
    September 21, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138345
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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: MALE. EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO BD ULTRA-FINE¿ SYRINGES WERE MISSING THE PLUNGER RODS, WHILE OTHER SYRINGES HAD DIFFICULT PLUNGER MOVEMENT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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# 8022941. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO BD ULTRA-FINE¿ SYRINGES WERE MISSING THE PLUNGER RODS, WHILE OTHER SYRINGES HAD DIFFICULT PLUNGER MOVEMENT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620889 BD ULTRA-FINE¿ SYRINGES PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8022941 00681131138345

    Patients

    Seq Age Sex Outcome Treatment
    1 Other