BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PER-Q-CATH PLUS 4F SINGLE-LUMEN PICC WITH SAFETY EXCALIBUR INTRODUCER

    MDR report key: 11388691 · Received February 26, 2021

    Report

    Report Number
    3006260740-2021-00543
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    February 2, 2021
    Report Date
    August 11, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741074899
    PMA / PMN Number
    K954104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAKING CATHETER WAS CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 5FR S/L PER-Q-CATH CATHETER. USAGE RESIDUES WERE OBSERVED THROUGHOUT THE SAMPLE. AN ATTEMPT TO INFUSE WATER THROUGH THE SAMPLE USING A 12ML SYRINGE REVEALED THE SAMPLE TO BE PATENT TO INFUSION; HOWEVER, A SPRAYING LEAK WAS OBSERVED EMANATING FROM A SMALL HOLE BETWEEN THE 1CM AND 2CM DEPTH MARKINGS. TACTILE INSPECTION OF THE SAMPLE REVEALED TENSILE WEAKNESS IN THE VICINITY OF THE SPLIT. MICROSCOPIC INSPECTION OF THE SPLIT REVEALED A COARSELY STRIATED FRACTURE SURFACE. SURFACE ABRASIONS WERE OBSERVED IN THE VICINITY OF THE SPLIT, INCLUDING CIRCUMFERENTIALLY OPPOSITE THE SPLIT. THE SPLIT CHARACTERISTICS, SURFACE ABRASIONS AND TENSILE WEAKNESS WERE CONSISTENT WITH DAMAGE CAUSED BY CONTACT BETWEEN THE CATHETER AND A TRAUMATIC GRASPING INSTRUMENT SUCH AS FORCEPS OR HEMOSTATS. THE PRODUCT IFU STATES ¿AVOID ACCIDENTAL DEVICE CONTACT WITH SHARP ISNTRUMENTS AND MECHANICAL DAMAGE TO THE CATHETER MATERIAL. USE ONLY SMOOTH-EDGED ATRAUMATIC CLAMPS OR FORCEPS.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT FROM RESPIRATORY DEPARTMENT HAD A PQC CATHETER PLACED UNDER ULTRASOUND ON (B)(6) 2020. 38 CM OF THE CATHETER WAS PLACED IN THE BODY, AND ANOTHER 7 CM OF THE CATHETER WAS EXPOSED EXTERNALLY. FLUID LEAKS OCCURRED WHEN INFUSION WAS CONDUCTED. ON (B)(6) 2021, THE PROBLEM PERSISTED. CONSULTATIONS BY CATHETER PLACEMENT CLINIC FOUND THAT THE CATHETER LEAKED FLUIDS AT THE 1 CM SCALE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF RECR2697 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT FROM RESPIRATORY DEPARTMENT HAD A PQC CATHETER PLACED UNDER ULTRASOUND ON (B)(6) 2020. 38 CM OF THE CATHETER WAS PLACED IN THE BODY, AND ANOTHER 7 CM OF THE CATHETER WAS EXPOSED EXTERNALLY. FLUID LEAKS OCCURRED WHEN INFUSION WAS CONDUCTED. ON (B)(6) 2021, THE PROBLEM PERSISTED. CONSULTATIONS BY CATHETER PLACEMENT CLINIC FOUND THAT THE CATHETER LEAKED FLUIDS AT THE 1 CM SCALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285858 PER-Q-CATH PLUS 4F SINGLE-LUMEN PICC WITH SAFETY EXCALIBUR INTRODUCER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A RECR2697 00801741074899

    Patients

    Seq Age Sex Outcome Treatment
    1 Other