BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD DELUXE GUIDEWIRE PEG SYSTEM 20F WITH SOFT SILICONE RE

    MDR report key: 3181985 · Received June 17, 2013

    Report

    Report Number
    3006260740-2013-00307
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 30, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF THE JOINT SEPARATING IS INCONCLUSIVE DUE TO THE CONDITION OF THE SAMPLE. UPON RECEIPT THE PLASTIC WRAP SLEEVE WAS IDENTIFIED AND IS LOCATED BETWEEN THE 6 AND 9 CM DEPTH MARKERS. MAGNIFICATION OF THE SHRINK WRAP REVEALED MULTIPLE FOLDS. THE SHRINK WRAP SLEEVE HAS SEPARATED FROM THE FEEDING TUBE/DILATOR CONNECTOR JOINT AND SLID AWAY DURING THE PLACEMENT PROCEDURE. A CROSS SECTIONAL VIEW OF THE PROXIMAL END OF THE FEEDING TUBE EXHIBITS A SMOOTH AND STRIATED CUT. THIS IS INDICATIVE OF A CUT WITH A SHARP INSTRUMENT SUCH AS A KNIFE OR SCALPEL. THE DILATOR AND PLASTIC JOINT WAS NOT RETURNED FOR EVALUATION. STRESSES DURING THE PLACEMENT PROCEDURE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. HOWEVER, WITHOUT THE COMPLETE SAMPLE THE MECHANISM OF THE FAILURE IS UNDETERMINED. A LOT HISTORY REVIEW (LHR) OF HUWK1454 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT (S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    JOINT ON PEG TUBING, SEPARATED FROM THE PEG ITSELF AND AS THE DOCTOR PULLED THE PRODUCT THROUGH THE PT'S STOMACH, A PIECE HAS STAYED INSIDE THE PT AND HAD TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272940 BARD DELUXE GUIDEWIRE PEG SYSTEM 20F WITH SOFT SILICONE RE KNT C. R. BARD INC. (BASD) HUWK1454

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention