BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45 CM 5 FR D/L GROSHONG NXT BASIC WITH TLS

    MDR report key: 2892535 · Received December 26, 2012

    Report

    Report Number
    3006260740-2012-00473
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Report Date
    December 3, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K060341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY REVIEW (LHR): LOT # REWF1803, LOT SIZE ((B)(4) OF UNITS RELEASED TO DISTRIBUTION): (B)(4), SIMILAR COMPLAINT RECORDS: NONE, QUANTITY AFFECTED (THIS AND SIMILAR COMPLAINTS): COMPLAINT THRESHOLD (BASED ON LOT SIZE AND SEVERITY): THE COMPLAINT THAT THE STYLET BROKE WAS CONFIRMED BUT THE CAUSE IS UNK. THE PRODUCT RETURNED FOR EVAL WAS A TLS STYLET WITH THE T-LOCK ASSEMBLY. THE STYLET WAS RETURNED IN TWO SEGMENTS. THE PROXIMAL SEGMENT WAS 24.3" LONG WHILE THE OTHER RETURNED SEGMENT WAS 4.2" LONG. MICROSCOPIC EXAMINATION CONFIRMED THAT BOTH ENDS OF THE SMALLER SEGMENT CONTAINED BREAK EDGES AND THE DISTAL SEGMENT, WHICH CONTAINS THE EPOXY TIP, WAS NOT RETURNED FOR EVAL. IT APPEARED THAT THE POLYIMIDE TUBING HAS BEEN ELONGATED. THE POLYIMIDE TUBING WAS COMPRESSED AND TWISTED AROUND THE CORE WIRE THROUGHOUT MOST OF THE STYLET. MICROSCOPIC EXAMINATION REVEALED THAT THE STYLET CONTAINED A PREDOMINATELY GLOSSY AND TRANSLUCENT VENEER. THE BLUE SHRINK TUBING WAS SEEN CRUMPLED WITHIN THE POLYIMIDE TUBING, WHICH CAN OCCUR AS A RESULT OF A TENSILE BREAK. MULTIPLE INTRA-MAGNETIC BREAKS WERE SEEN IN THE MAGNETS NEAR THE BREAK SITE. MICROSCOPIC EXAMINATION OF THE BREAK SURFACES REVEALED A GRANULAR TEXTURE AND COMPRESSED TUBING. THE PROXIMAL STYLET SEGMENT WAS MADE TO REMOVE THE STYLET FROM THE CATHETER, BOTH WHEN THE CATHETER WAS HELD IN A SINGLE AND A DOUBLE CURVE CONFIGURATION. ALTHOUGH THE BENDS IN THE WIRE COULD BE FELT MOVING THROUGH THE CATHETER, THE STYLET COULD BE REMOVED PER DESIGN AND WITHOUT UNUSUAL RESISTANCE. THE REPORTED RESISTANCE UPON REMOVAL COULD NOT BE REPRODUCED ON THE RETURNED SAMPLE. HOWEVER, THE COMPLAINT OF A LEAK IN THE STYLET WAS CONFIRMED. IT IS UNK OF OTHER INFO NOT HYDRATING THE STYLET PRIOR TO REMOVAL, CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    WHEN REMOVING THE WIRE, THE NURSE NOTED THAT THE FIRST 10CM REMOVED SMOOTHLY, AND THEN BECAME "TIGHTER". ONCE THE PICC WAS INSPECTED APPROX 10CM OF WIRE WAS DISCOVERED AT DISTAL END OF ORIGINAL PICC (WITHIN LUMEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45 CM 5 FR D/L GROSHONG NXT BASIC WITH TLS FOZ C. R. BARD INC. (BASD) REWF1803

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention