BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMICATH

    MDR report key: 20751873 · Received November 21, 2024

    Report

    Report Number
    2245270-2024-00112
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    November 17, 2024
    Report Date
    February 24, 2025
    Manufacturer
    VYGONGMBH
    Product Code
    LJS
    PMA / PMN Number
    K954302
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MALFUNCTIONING DEVICE WILL BE RETURNED TO VYGON. UPON RECEIPT, IT WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THE INVESTIGATION WILL BE COMMUNICATED TO THE FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA A FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 0

    WE RECEIVED THE CATHETER CONNECTED TO A YELLOW CANNULA (NON-VYGON GERMANY GMBH PRODUCT) AS FAULTY SAMPLE. THE CATHETER TUBE SNAPPED AT THE 8 CM MARKING. MICROSCOPIC EXAMINATION REVEALED A DIAGONAL FRACTURE WITH SMOOTH SURFACES, SUGGESTING MECHANICAL DAMAGE CAUSED BY A SHARP INSTRUMENT, SUCH AS A SCALPEL OR SIMILAR. THE ROOT CAUSE WAS ALSO CONFIRMED BY THE ANALYSIS FROM THE TECHNICAL DEPARTMENT AT VYGON (UK) LTD, WHICH NOTED THAT THE SMOOTH ASPECT OF THE TEAR SURFACE INDICATES THE CATHETER CAME INTO CONTACT WITH A SHARP IMPLEMENT. OBVIOUSLY, THE SAMPLE HAD BEEN PLACED WITH A CANNULA WHICH WAS RETURNED ALONG WITH THE SAMPLE. THE CODE 1261.208 IS A CATHETER WITH WING AND IS NOT SUITED WITH THE USE OF AN IV CANNULA AS THEY DO NOT FIT TOGETHER. FRICTION AND MOVEMENT IS THE RESULT WHICH CAN ALSO WEAKEN THE CATHETER AND MAKE IT LESS TOLERANT TO APPLIED TENSILE FORCES. FOR THIS KIND OF USAGE THE CUSTOMER SHOULD APPLY E.G. CODE 1261.206 WITH PINK LUER-ADAPTER WHICH FIT TO THE LL-HUB OF A IV CANNULA. OR THE CUSTOMER SHOULD USE THE CLAIMED CODE TOGETHER WITH A MICROFLASH INTRODUCER OR PEELABLE NEEDLE FROM VYGON. HAVING CHECKED THE BATCH HISTORY RECORDS; NO DEVIATIONS WERE FOUND. THE BATCH COMPLIED WITH ITS SPECIFICATION AND WAS RELEASED. THE TENSILE FORCE AND DIMENSIONS OF CATHETER AND SET COMPONENTS ARE RANDOMLY CHECKED. ONE BATCH WAS USED FOR THE ASSEMBLY GROUP OF THE CATHETER TUBE (INVOLVED CODE 6G35961012). THE VALUE OF THE TENSILE FORCE OF THE CATHETER TUBE FOR BATCH 8237078 WAS MIN. 3.38 N AND THEREFORE WITHIN ITS SPECIFICATION (MIN. 1.5 N). THERE IS ONE FURTHER COMPLAINT FOR BATCH 240524GV AND ONE FURTHER COMPLAINT REGARDING A SNAPPED/CUT CATHETER TUBE WHICH HAD TO BE SURGICALLY REMOVED ON CODE 1261.208 WITHIN THE LAST THREE YEARS. THIS QUERY RELATES TO ALL COMPLAINTS THAT HAVE COME TO OUR ATTENTION WORLDWIDE. HOWEVER, THIS FURTHER COMPLAINT WAS NOT RELATED TO A MANUFACTURING FAULT. NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT AS THERE IS NO HINT OF A MANUFACTURING FAULT.

    Description of Event or Problem · 0

    LINE SNAPPED AND REMAINED IN PATIENT, REQUIRED OPERATION TO REMOVE. SURGICAL REMOVAL OF THE SNAPPED CATHETER FRAGMENT WAS NECESSARY. NO PATIENT INFORMATION.

    Description of Event or Problem · 0

    LINE SNAPPED AND REMAINED IN PATIENT, REQUIRED OPERATION TO REMOVE. INCIDENT OCCURRED ON (B)(6)2024, IN SITU FOR 13 DAYS. SURGICAL REMOVAL OF THE SNAPPED CATHETER FRAGMENT WAS NECESSARY. NO PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631936 PREMICATH INTRAVASCULAR CATHETER LJS VYGONGMBH 1261.208 240524GV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention