BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN120 W/O BP

    MDR report key: 12147741 · Received July 9, 2021

    Report

    Report Number
    2243072-2021-01848
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 10, 2021
    Report Date
    June 24, 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 IN SECTIONS 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 FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: A SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. SBDM NOTICED THAT THERE IS NO PRINTING ON THE PACKAGE. SBDM FOUND THAT THERE WAS NO PRINTING INFORMATION OF MANUFACTURING NUMBER, MANUFACTURING DATE, AND LOT NUMBER. EXT SET PROCESS FLOW CHART: AS A RESULT OF INVESTIGATION ACTIVITIES TO FIND THE ROOT CAUSE OF THE COMPLAINT SAMPLE, IT MAY BE OCCURRED WHILE INDIVIDUAL PACKING FILM PRINTING PROCESS. HOUSE SAMPLE INSPECTION: SBDM TOTALLY CHECKED 30 HOUSE SAMPLES OF THE COMPLAINT PRODUCT (IV SET AN120 W/O BP, LOT NO. 2105174, 2105201 & 2105271), STORED IN THE COMPANY, THERE WAS NO DEFECTIVE PRODUCT FOUND IN THEM. DHR REVIEW: SBDM CHECKED MANUFACTURING RECORDS SUCH AS RECEIVING INSPECTION REPORT, PROCESS INSPECTION REPORT AND FINISHED PRODUCT TEST REPORT OF THE SUSPECTED HOUSE SAMPLES, THERE WAS NO ABNORMALITY ON THE MANUFACTURING RECORDS. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEW THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE IS SIMILAR ISSUE OF THE DIFFERENT PRODUCT FROM SAME CUSTOMER. ROOT CAUSE: BASED ON INVESTIGATION RESULT OF THE COMPLAINT CASE, THERE IS NO PRINTING ON THE PACKAGE, SBDM FOUND THAT THERE WAS NO PRINTING INFORMATION OF MANUFACTURING NUMBER, MANUFACTURING DATE, AND LOT NUMBER. THE LIKELY CAUSE IS THAT IT MAY BE OCCURRED WHILE INDIVIDUAL PACKING FILM PRINTING PROCESS. WHEN PRINTING ON THE INDIVIDUAL FILM, THERE MIGHT BE 2 FILMS WERE STICK TOGETHER DUE TO STATIC ELECTRONICS. AND PACKING LINE WORKERS AND INSPECTORS DID NOT FIND THE INDIVIDUAL FILM WITHOUT PRINTING. THEREFORE, IT CAUSED THIS COMPLAINT CASE. CORRECTIVE ACTIONS: QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR EXTENSION SET INDIVIDUAL FILM PRINTING & PACKING WORKERS AND QUALITY INSPECTORS. IMPLEMENTING TIGHTENED PRODUCT & PROCESS MONITORING AND STRENGTHENING QUALITY INSPECTION FOR EXTENSION SET PROCESS INSPECTION. PREPARING THE INDIVIDUAL FILMS TO PREVENT STICK TOGETHER BY BENDING THE BUNCH OF INDIVIDUAL FILM. CONDUCTING INSPECTION FOR ALL PRODUCT IN SEALING PROCESS TO PREVENT NO PRINTING ON AN INDIVIDUAL FILM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME OF THE IV SET AN120 W/O BP LABEL PRINTING WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE IS NO PRINTING ON THE PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042661 IV SET AN120 W/O BP INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1