BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NON-VENTED MALE LL CAP

    MDR report key: 15518947 · Received September 30, 2022

    Report

    Report Number
    2243072-2022-01703
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    September 7, 2022
    Report Date
    November 1, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    70885403483976
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN MANUFACTURER NAME, CITY AND STATE AND MANUFACTURER SITE 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. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0001097691, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 29-JUL-2017; MEDICAL DEVICE LOT #: 0004167973, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 19-DEC-2020.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A COMPLAINT OF DISCOLORATION OF THE NON-VENTED MALE LUER CAPS WAS RECEIVED FROM THE CUSTOMER. PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. IN THE PHOTOS THE COMPONENT CAN BE SEEN. SINCE NO PHYSICAL SAMPLES WERE AVAILABLE FOR REVIEW, THE DEFECT CANNOT BE CONFIRMED. THE LOTS 0001097691 AND 0004167973 WERE MANUFACTURED BY VYAIRE. THE MOLDS HAVE NOW BEEN MOVED TO THE NORTH AMERICAN MOLDING CENTER (NAMC), AND DHR INFORMATION COULD NOT BE OBTAINED FROM VYAIRE. A REVIEW OF QUALITY NOTIFICATIONS WAS PERFORMED BY NAMC WITH NO RECORD OF DISCOLORATION BEING REPORTED SINCE MOLDING OF THIS COMPONENT BEGAN. NAMC WILL BE MONITORING THIS DEFECT IN THE EVENT OF OCCURRENCE THROUGH THE VISUAL AND FIRST PIECE INSPECTION CONTROLS PLACED IN PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NON-VENTED MALE LL CAP HAD A DIFFERENT COLOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM KOREAN TO ENGLISH: THE CUSTOMER (BD) THAT THE COLOR OF STYLET CAP FROM CAREFUSION IS DIFFERENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NON-VENTED MALE LL CAP HAD A DIFFERENT COLOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM KOREAN TO ENGLISH: THE CUSTOMER(BD) THAT THE COLOR OF STYLET CAP FROM CAREFUSION IS DIFFERENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2185600 BD NON-VENTED MALE LL CAP INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON SEE H.10 70885403483976

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown