BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER TIP CAP STERILE TRAY

    MDR report key: 8125214 · Received December 3, 2018

    Report

    Report Number
    1213809-2018-00865
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 16, 2018
    Report Date
    January 21, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO ACTUAL COMPLAINT SAMPLES WERE RECEIVED. REPRESENTATIVE SAMPLES WERE RECEIVED AND EVALUATED. THE SAMPLES WERE A SEALED CUBE OF 4 SHELF CARTONS (1000 EA X 4) FROM BATCH # 8149998 (P/N 305822). EACH PACKAGE WITH CAP TIPS INSIDE IT WITHIN EACH CARTON WAS VISUALLY EVALUATED. NO FOREIGN MATTER, INCLUDING MOLD, WAS FOUND IN ANY OF THE PACKAGES. ALL PRODUCT WAS OBSERVED TO BE CLEAN AND ABSENT OF FOREIGN MATTER. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE TWO PROVIDED LOT NUMBER(S) THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ LUER TIP CAP STERILE TRAY HAS MOLD. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8149998. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2018-05-29. MEDICAL DEVICE LOT #: 8087811. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2018-03-28. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ LUER TIP CAP STERILE TRAY HAS MOLD. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965283 BD¿ LUER TIP CAP STERILE TRAY LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other