BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSENTHAL BIOPSY NEEDLE

    MDR report key: 3028292 · Received March 27, 2013

    Report

    Report Number
    1213649-2013-00005
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    CADENCE INC
    Product Code
    GAA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CADENCE ACKNOWLEDGES THIS REPORT DOES NOT MEET THE THIRTY DAY REPORTING REQUIREMENT. THIS WAS UNINTENTIONAL. THIS REPORT IS BEING FILED AFTER IT WAS IDENTIFIED AS NON-COMPLIANT DURING AN INTERNAL REVIEW OF OUR COMPLAINT FILES. WHILE THE ACTUAL DEVICE WAS NOT RETURNED FOR EVAL, THE REPORTED NEEDLE BENT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE. THE CAUSE OF HE NEEDLE BENT COULD NOT BE DETERMINED FROM THE PHOTOGRAPH.

    Description of Event or Problem · 1

    ON (B)(6) 2012, DURING A BONE MARROW BIOPSY PROCEDURE, THE NEEDLE BENT THE FIRST TIME IT WAS USED. IT WAS ALSO REPORTED THAT TWO OTHER SIMILAR CADENCE NEEDLE DEVICES USED DURING THIS PROCEDURE ALSO BENT WHEN USED FOR THE FIRST TIME. THREE ATTEMPTS HAVE BEEN MADE TO RECEIVE ADD'L INFO ABOUT THE INCIDENT, BUT NONE HAS BEEN RECEIVED TO DATE. IF FURTHER INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125216 ROSENTHAL BIOPSY NEEDLE NEEDLE GAA CADENCE INC 7553 74869-01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK