BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F

    MDR report key: 9287351 · Received November 6, 2019

    Report

    Report Number
    3006260740-2019-03480
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 17, 2019
    Report Date
    January 17, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741138973
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, COMPLAINT AND LOT HISTORY REVIEW, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE EVALUATION, APPLICABLE FMEA DOCUMENTS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A CATHETER LEAK WAS CONFIRMED AND THE CAUSE APPEARS TO BE USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS 4FR S/L POWERPICC SOLO CATHETER. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE ACCUMULATED THROUGH FLEXURAL FATIGUE. FLEXURAL FATIGUE OCCURS DUE TO CYCLIC KINKING OF THE CATHETER TUBE IN WHICH PHYSIOLOGICAL, PLACEMENT, USAGE, AND MECHANICAL FACTORS MAY GRADUALLY FORM A CRACK(S) IN THE CATHETER. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND A SPLIT WAS OBSERVED BETWEEN THE 8CM & 9CM DEPTH MARKINGS (9.6CM DISTAL OF THE MOLDED JOINT). THE CATHETER SPLIT CONTAINED PHYSICAL FEATURES ASSOCIATED WITH MATERIAL FATIGUE, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: ¿ DAMAGE WHICH WAS CIRCUMFERENTIALLY ALIGNED ¿ FRACTURE EDGES WHICH WERE ROUNDED AND POLISHED DUE TO REPEATED MATERIAL WEAR ¿ 'C' SHAPED IMPRESSIONS LEADING INTO THE FRACTURE SITE WHICH ARE CONSISTENT WITH MATERIAL BUCKLING DUE TO MOVEMENT WHICH CAUSED THE FRACTURE EDGES TO BE PRESSED TOGETHER ¿ OVERALL ELLIPTICAL SHAPE TO THE FRACTURE CROSS-SECTION (A RESULT OF REPEATED KINKING OF THE TUBING) AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. A LOT HISTORY REVIEW (LHR) OF REDN2233 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED PICC INSERTED 190516 AND USED FOR NEOADJUVANT CHEMO. LAST CHEMO GIVEN WAS (B)(6)2019 . IT WAS REPORTED THAT ON A DOCTORS VISIT TO START ADJUVANT CHEMO, WHEN FLUSHING THE CATHETER THERE WAS LEAKAGE AT THE INSERTION SITE. THE CATHETER WAS PULLED AND WHEN FLUSHING IT OUTSIDE THE PATIENT THERE WAS A HOLE AT 10.5 CM. AT INSERTION THE CATHETER WAS 7 CM OUTSIDE THE PATIENT AND THE CATHETER WAS SECURED BY SECURACATH.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REDN2233 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED PICC INSERTED 190516 AND USED FOR NEOADJUVANT CHEMO. LAST CHEMO GIVEN WAS (B)(6) 2019. IT WAS REPORTED THAT ON A DOCTORS VISIT TO START ADJUVANT CHEMO, WHEN FLUSHING THE CATHETER THERE WAS LEAKAGE AT THE INSERTION SITE. THE CATHETER WAS PULLED AND WHEN FLUSHING IT OUTSIDE THE PATIENT THERE WAS A HOLE AT 10.5 CM. AT INSERTION THE CATHETER WAS 7 CM OUTSIDE THE PATIENT AND THE CATHETER WAS SECURED BY SECURACATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081578 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A REDN2233 00801741138973

    Patients

    Seq Age Sex Outcome Treatment
    1