BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURETRANS A/T

    MDR report key: 6726409 · Received July 19, 2017

    Report

    Report Number
    1213643-2017-00416
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Report Date
    July 19, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    CAC
    PMA / PMN Number
    K913247
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL MDR IS BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE REVIEW OF DAVOL¿S MDR DECISIONS AND THE INITIAL DECISION NOT TO REPORT THE EVENT IS BEING REVISED TO REFLECT UPDATED COMPANY PROCEDURES. FUNCTIONAL EVALUATION OF THE COMPLAINT SAMPLE IDENTIFIED A PUNCTURE/ HOLE ON THE CLEAR SIDEWALL OF THE SOLCOVAC 3-SPRING EVACUATOR CAUSING IRREGULAR RATE OF ASPIRATION IN THE DEVICE. AT THIS POINT IS UNCLEAR HOW OR WHAT CAUSED THE PUNCTURE TO THE CLEAR SIDEWALL, ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THE INFORMATION PROVIDED BY BARD 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 BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO DAVOL (B)(4), THAT DURING TESTING AT DAVOL, WHEN THE SPRING EVACUATOR WAS COMPRESSED, THE DEVICE APPEARED TO BE ASPIRATING SLOWER THAN WHAT IS SPECIFIED. THE ISSUE WAS RESOLVED BY ISOLATING THE 3-SPRING EVACUATOR, COMPRESSING IT THREE TIMES AND SEALING IT. BASED ON THE OBSERVATION OF THE QE, A LEAK EXISTS IN THE 3-SPRING EVACUATOR. THE PACKAGING APPEARED TO BE FINE, AND NOTHING OUT OF THE ORDINARY WAS OBSERVED WHILE OPENING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506314 SURETRANS A/T AUTOTRANSFUSION SYSTEM CAC DAVOL INC., SUB. C.R. BARD, INC. NA JUZAF530

    Patients

    Seq Age Sex Outcome Treatment
    1