BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULL PEG SD 20F PULL KIT

    MDR report key: 2093321 · Received April 15, 2011

    Report

    Report Number
    3006260740-2011-00108
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 24, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONFIRMED. UPON RECEIPT THE INTRODUCER SHEATH REVEALED MULTIPLE TWISTED FOLDS. THE DISTAL TIP OF THE SHEATH IS JAGGED AND IRREGULAR. THE COMPLAINT INCIDENT COULD NOT BE REPLICATED IN THE LABORATORY SETTING. IT APPEARS, THE INTRODUCER SHEATH HAS BEEN DAMAGED THROUGH USE, HOWEVER, AT THIS TIME THE MECHANISM OF DAMAGE UNDETERMINED. A CHR OF LOT# HUUH1023 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    DURING THE PLACING OF THE DEVICE, THERE IS A PROBLEM DURING THE INSERTION OF THE TROCAR WHICH BEGAN PLEATED ON THE SKIN. THE DOCTOR REMOVED IT BUT THERE IS AN AIR PASSAGE IN INTRA-PERITONEAL. THE PROCEDURE WAS STOPPED BECAUSE OF A PNEUMOPERITONEUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULL PEG SD 20F PULL KIT KNT C. R. BARD INC. (BASD) HUUH1023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention