BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN120 W/O BP

    MDR report key: 12256558 · Received July 30, 2021

    Report

    Report Number
    2243072-2021-02001
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 2, 2021
    Report Date
    July 19, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. VISUAL INSPECTION COMPARES WITH RETENTION SAMPLE: SBDM FOUND THAT CHAMBER AND SPIKE ARE DISCONNECTED IN THE RECEIVED SAMPLE. HOUSE SAMPLE INSPECTION: SBDM INSPECTED THE LOT NO. (LOT NO 2102102, 2102231 & 2104032) AS OF THE HOUSE SAMPLES, THERE WAS DISCONNECTED SPIKE AND CHAMBER. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD OF COMPLAINT SAMPLE, THERE IS NO ISSUE WHILE MANUFACTURING. CUSTOMER COMPLAINT RECORD REVIEW OF COMPLAINT SAMPLE: SBDM REVIEW THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE WAS NO SAME ISSUE OF THE SAME PRODUCT FROM OTHER CUSTOMER. ROOT CAUSE: FROM INVESTIGATIONS OF CHECKING OUR SPIKE & CHAMBER ASSEMBLY PROCESS, THE LIKELY CAUSE IS THAT THERE MAY BE A TEMPORARY MALFUNCTION IN THE ASSEMBLY MACHINE AND INSUFFICIENT ADHESIVE MAY BE PUT IT ON DURING THE STAGE OF ADHESIVE PUTTING ON THE SPIKE SURFACE. AND IT MAY BE THE CAUSE OF THE COMPLAINT CASE. CORRECTIVE ACTIONS: QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR IV SET MANUFACTURING PROCESS WORKERS AND QUALITY INSPECTORS. STRENGTHENING IN-PROCESS INSPECTION AS WELL AS FINISHED PRODUCT INSPECTION FOR IV SET MANUFACTURING LINE. CHECKED THE SPIKE + CHAMBER ASSEMBLY MACHINE AND TOOK PREVENTIVE MAINTENANCE ON IT. IMPLEMENTING 100% INSPECTION FOR SPIKE+CHAMBER ASSEMBLED PARTS EFFECTIVE. COMPLAINTS FOR THE DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED FOR FUTURE OCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IV SET AN120 W/O BP CHAMBER DETACHED FROM THE SPIKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE USER STARTED TO USE IV SET, THE CHAMBER HAD BEEN DETACHED FROM THE SPIKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149156 IV SET AN120 W/O BP INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1