BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® EXTENSION CABLE

    MDR report key: 9757134 · Received February 26, 2020

    Report

    Report Number
    1018233-2020-01358
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    January 31, 2020
    Report Date
    April 2, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741045875
    PMA / PMN Number
    K070582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED AS THE DEVICE MET SPECIFICATIONS. EVALUATION REPORT OF THE RETURNED SAMPLE, SUBMITTED BY WONIK CORPORATION, STATES THAT WHEN CONTINUITY TESTS WERE PERFORMED ON THE SAMPLES, ALL OF THEM PASSED. THE RESISTANCE VALUES OF ALL THE SAMPLES WERE CHECKED AND THEY WERE BELOW 0.7 OHM AT POSITIVE AND 0.3 OHM AT NEGATIVE. DIELECTRIC TEST WAS PERFORMED ON EACH SAMPLE BY APPLYING 1KV ONTO 6.3MM PLUG AND 500V CONNECTING TO 3.5MM JACK. IT WAS FOUND THAT THERE WAS NO SHORT CIRCUIT. A DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED PER THE INVESTIGATION. THE REPORTED EVENT IS UNRELATED TO LABELING. THEREFORE, A LABELING REVIEW IS NOT REQUIRED. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A FEW MONTHS OF USE WITH THE EXTENSION CORD, THE PATIENT BODY TEMPERATURE ON THE MONITOR DID NOT DISPLAY ACCURATELY OR DISAPPEARED. IF A NEW EXTENSION CORD WAS USED, THE CORRECT BODY TEMPERATURE WAS DISPLAYED. REPORTEDLY, THERE WAS NO PROBLEM WITH THE MONITOR OR FOLEY CATHETER. THE EXTENSION CORD WAS THE ALLEGED ISSUE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A FEW MONTHS OF USE WITH THE EXTENSION CORD, THE PATIENT BODY TEMPERATURE ON THE MONITOR DID NOT DISPLAY ACCURATELY OR DISAPPEARED. IF A NEW EXTENSION CORD WAS USED, THE CORRECT BODY TEMPERATURE WAS DISPLAYED. REPORTEDLY, THERE WAS NO PROBLEM WITH THE MONITOR OR FOLEY CATHETER. THE EXTENSION CORD WAS THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223349 BARD® EXTENSION CABLE EXTENSION CORD EZL C.R. BARD, INC. (COVINGTON) -1018233 153622 UNK 00801741045875

    Patients

    Seq Age Sex Outcome Treatment
    1