BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    US CATHENA 22GX1.00IN STRAIGHT BC

    MDR report key: 11774422 · Received May 4, 2021

    Report

    Report Number
    8041187-2021-00377
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 7, 2021
    Report Date
    May 27, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903868612
    PMA / PMN Number
    K201717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS AND ONE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO AND SAMPLE, THE NEEDLE PIERCED THROUGH CATHETER WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. THE ASSEMBLY PROCESS WAS REVIEWED. IF THE NEEDLE PIERCED THROUGH CATHETER OCCURRED IN THE MANUFACTURING PROCESS, THE DEFECT WOULD BE DETECTED AND AUTO-REJECTED BY THE AUTOMATED VISION INSPECTION SYSTEM DUE TO NOT MEETING THE LIE DISTANCE REQUIREMENT. THIS NONCONFORMANCE COULD HAVE OCCURED DURING PRODUCT APPLICATION WHEN THE PRODUCT WAS MANIPULATED. AS THE SAMPLES WERE RETURNED IN OPEN PACKAGING AND HAD BEEN USED IN APPLICATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT US CATHENA 22GX1.00IN STRAIGHT BC CATHETER SPLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 386813 BATCH NO: 0023846) IT WAS REPORTED THE CATHETER SPLIT. VERBATIM: THE NURSE (PEDS M20) WAS TRYING TO PLACE A 22G CATHENA CATHETER AND CLAIMS THAT THE CATHETER SPLIT. THEY SAID THAT THEY WERE TRYING TO PLACE THE IV AND IT WOULD NOT ADVANCE AND THE CATHETER SPLIT. WE ASKED IF THEY HAD PULL BACK THE NEEDLE AND THEN ATTEMPTED TO THREAD BUT THEY SAID NO.

    Additional Manufacturer Narrative · 1

    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 US CATHENA 22GX1.00IN STRAIGHT BC CATHETER SPLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 386813 BATCH NO: 0023846). IT WAS REPORTED THE CATHETER SPLIT. VERBATIM: THE NURSE (PEDS M20) WAS TRYING TO PLACE A 22G CATHENA CATHETER AND CLAIMS THAT THE CATHETER SPLIT. THEY SAID THAT THEY WERE TRYING TO PLACE THE IV AND IT WOULD NOT ADVANCE AND THE CATHETER SPLIT. WE ASKED IF THEY HAD PULL BACK THE NEEDLE AND THEN ATTEMPTED TO THREAD BUT THEY SAID NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670177 US CATHENA 22GX1.00IN STRAIGHT BC CATHETER, INTRAVASCULAR, THERAPEUTIC FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 386861 0023846 00382903868612

    Patients

    Seq Age Sex Outcome Treatment
    1