BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUISTREAM XK CATHETER

    MDR report key: 8528525 · Received April 18, 2019

    Report

    Report Number
    3006260740-2019-00969
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    November 6, 2018
    Report Date
    June 6, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    UDI-DI
    00801741013836
    PMA / PMN Number
    K090101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: THE LOT MET ALL RELEASE CRITERIA. DHR WAS REVIEWED AND NO DEVIATIONS/ISSUES WERE IDENTIFIED ASSOCIATED WITH THIS PROBLEM IN REGARDS TO PRODUCT MATERIALS OR DURING PACKAGING, MANUFACTURING OR QC INSPECTION PROCESSES. ALL NECESSARY INSPECTIONS WERE PERFORMED THROUGHOUT ALL THE MANUFACTURING, PACKAGING AND INSPECTION ACTIVITIES AND FOR RAW MATERIAL UTILIZED IN THE MANUFACTURE OF THIS LOT, IN REGARDS TO THE DESCRIBED PROBLEM. INVESTIGATION SUMMARY: THE COMPLAINT DUE TO ¿THE PEEL-AWAY SHEATHS WERE ALLEGEDLY INCOMPATIBLE FOR THE PACKAGED CATHETER¿ IS CONFIRMED. ACCORDING WITH THE PHOTO VISUAL EVALUATION AND BPV INVESTIGATION PERFORMED WAS CONCLUDE THAT THE FRENCH SIZE OF THE SHEATH PACKED IN THE SAMPLE HAD AN INCORRECT FRENCH SIZE ACCORDING TO THE PRODUCT LABEL, EITHER THE INCORRECT PRODUCT WAS PACKAGED INTO THE KIT OR AN INCORRECT SHEATH WAS USED DURING THE PACKAGING PROCESS OF THE KIT. DUE TO THIS THE COMPLAINT IS CONFIRMED AS MANUFACTURING RELATED. TWO EQUISTREAM XK CATHETER KITS WERE RETURNED FOR EVALUATION. FUNCTIONAL, GROSS VISUAL, AND TACTILE EVALUATIONS WERE PERFORMED. THE INVESTIGATION IS CONFIRMED FOR INCORRECT COMPONENT, AS VISUAL EVALUATION CONFIRMED THAT BOTH SHEATHS WERE 15FR AND THE PRODUCT CATALOG NUMBER 5913190 INDICATES THAT THE CORRECT SIZE IS 16.5FR. FUNCTIONAL TESTING CONFIRMED THAT THE CATHETERS WERE UNABLE TO BE PASSED THROUGH THE SHEATH FOR BOTH SAMPLES. BOTH SAMPLES WERE RECEIVED WITH THE KITS SEALED. EXPIRY DATE: 4/2020.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION FOR THE CHRONIC CATHETER PLACEMENT, TWO KITS WERE OPENED AND THE PEEL-AWAY SHEATHS WERE ALLEGEDLY INCOMPATIBLE FOR THE PACKAGED CATHETER AND WERE RENDERED UNUSABLE. REPORTEDLY, ANOTHER TWO KITS WERE UNOPENED AND THE INCORRECT SIZE WAS ALLEGEDLY ABLE TO BE IDENTIFIED THROUGH THE CLEAR PACKAGING, THEREFORE, THE CUSTOMER ALLEGED THE FOUR KITS WERE PROVIDED WITH THE INCORRECT SIZE SHEATH. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS IMPLANTED. THERE WAS NO REPORTED PATIENT CONTACT.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 4/2020).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR THE CHRONIC CATHETER PLACEMENT, TWO KITS WERE OPENED AND THE PEEL-AWAY SHEATHS WERE ALLEGEDLY INCOMPATIBLE FOR THE PACKAGED CATHETER AND WERE RENDERED UNUSABLE. REPORTEDLY, ANOTHER TWO KITS WERE UNOPENED AND THE INCORRECT SIZE WAS ALLEGEDLY ABLE TO BE IDENTIFIED THROUGH THE CLEAR PACKAGING, THEREFORE, THE CUSTOMER ALLEGED THE FOUR KITS WERE PROVIDED WITH THE INCORRECT SIZE SHEATH. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS IMPLANTED. THERE WAS NO REPORTED PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320312 EQUISTREAM XK CATHETER CHRONIC CATHETER MSD BARD ACCESS SYSTEMS 5913190 RECT0999 00801741013836

    Patients

    Seq Age Sex Outcome Treatment
    1