BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMALE LL ADAPTOR

    MDR report key: 11131039 · Received January 7, 2021

    Report

    Report Number
    2243072-2021-00015
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 9, 2020
    Report Date
    January 8, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO SAMPLES OF THE MODEL 1022-085-032 (FEMALE LL ADAPTOR) WERE RECEIVED ON DECEMBER 21ST, 2020, IT WAS REPORTED PER CRACK, THE SAMPLES WERE REVIEWED, AND DURING VISUAL INSPECTION IT WAS OBSERVED A CRACK. SINCE THE REPORTED MODEL IS SUPPLIER RELATED, A MANUFACTURING INFORMATION WAS REQUESTED, THE SUPPLIER CONDUCTED A DHR REVIEW AND NO ISSUES WERE FOUND DURING THE MANUFACTURING OF THE REPORTED LOTS REGARDING TO THE DAMAGE AND IT WAS MANUFACTURED ACCORDING WITH SUPPLIER INTERNAL PROCEDURE, SINCE THE MOLD WAS TRANSFERRED AND NO ISSUES WERE FOUND DURING MANUFACTURING, THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINATE. AS IMMEDIATE ACTION, A SUPPLIER NOTIFICATION WAS SUBMITTED TO NAMC ON DECEMBER 09TH,2020 TO BE AWARE OF THIS ISSUE. NO ADDITIONAL PREVENTIVE OR CORRECTIVE ACTIONS WERE REQUIRED SINCE THE TOOL WAS TRANSFERRED TO A NEW SUPPLIER ON DECEMBER 2019. ADDITIONAL TO THIS, THE COMPONENT IS STILL UNDER VALIDATION PROCESS AT THE NEW SUPPLIER SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FEMALE LL ADAPTOR CRACKED. THIS OCCURRED ON 6 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 1022-085-032 BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE LUERS ARE CRACKING. VERBATIM: "WE¿VE JUST HAD A CUSTOMER RETURN REGARDING THE FINISHED PRODUCT THAT PN 12-197 (1022-085-032 DOW POLYCARBONATE FEMALE LUER LOCK - CLEAR. PER DRAWING # 1022-XXX-XXX, REV. D) IS USED ON. THE LEURS ARE CRACKING. I DON¿T HAVE A LOT OF INFORMATION RIGHT NOW, AS OUR QC TEAM IS WAITING ON THE CUSTOMER TO PROVIDE WHAT PRODUCTION JOB IT CAME FROM SO WE CAN TRACE IT BACK ON OUR END TO THE PURCHASE ORDER NUMBER. ORIGINALLY, IT SEEMED LIKE IT WAS ONLY FROM CAVITY 11, 15, AND 17 BUT THE EXAMPLES I WAS GIVEN ALSO HAVE CAVITY 1, 6, AND 7. OUR QC TEAM HAS INSPECTED SOME OF WHAT WE HAVE IN INVENTORY OF THE LEUR AND FINISHED PRODUCT, AND DID NOT SEEM TO FIND ANY ISSUES WITH CURRENT STOCK AT THIS TIME."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. 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. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FEMALE LL ADAPTOR CRACKED. THIS OCCURRED ON 6 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 1022-085-032 BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE LUERS ARE CRACKING. VERBATIM: "WEVE JUST HAD A CUSTOMER RETURN REGARDING THE FINISHED PRODUCT THAT PN 12-197 (1022-085-032 DOW POLYCARBONATE FEMALE LUER LOCK - CLEAR. PER DRAWING # 1022-XXX-XXX, REV. D) IS USED ON. THE LEURS ARE CRACKING. I DONT HAVE A LOT OF INFORMATION RIGHT NOW, AS OUR QC TEAM IS WAITING ON THE CUSTOMER TO PROVIDE WHAT PRODUCTION JOB IT CAME FROM SO WE CAN TRACE IT BACK ON OUR END TO THE PURCHASE ORDER NUMBER. ORIGINALLY, IT SEEMED LIKE IT WAS ONLY FROM CAVITY 11, 15, AND 17 BUT THE EXAMPLES I WAS GIVEN ALSO HAVE CAVITY 1, 6, AND 7. OUR QC TEAM HAS INSPECTED SOME OF WHAT WE HAVE IN INVENTORY OF THE LEUR AND FINISHED PRODUCT, AND DID NOT SEEM TO FIND ANY ISSUES WITH CURRENT STOCK AT THIS TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30343 FEMALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 0004100070

    Patients

    Seq Age Sex Outcome Treatment
    1