BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 5 FR 80CM

    MDR report key: 17052625 · Received June 2, 2023

    Report

    Report Number
    3010532612-2023-00306
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 16, 2023
    Report Date
    May 16, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DYG
    UDI-DI
    10801902180787
    PMA / PMN Number
    K892530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT THAT THE "CATHETER RUPTURED DURING POWER INJECTION" IS CONFIRMED. THE CUSTOMER RETURNED A 5FR. 80CM BERMAN CA THETER WITH THE ORIGINAL PACKAGING POUCH (INP-3) FOR INVESTIGATION. THE SAMPLE WAS RETURNED IN THE SUPPLIED RETURN KIT AND WAS IN A SEALED BIO-HAZARD BAG (INP-1, INP-2). THE SAMPLE WAS LOOSELY PACKED WITHIN THE ORIGINAL PACKAGING POUCH (INP-5). UPON RETURN, THE CATHETER BODY WAS IMMEDIATELY NOTED RUPTURED NEAR THE JUNCTION HUB; THE BODY WAS NOTED RUPTURED FROM APPROXIMATELY 88.3CM TO 88.9CM FROM THE DISTAL TIP OF THE CATHETER (INP-9, INP-10). THE SUPPLIED CONTROL STROKE SYRINGE WAS NOT RETURNED WITH THE SAMPLE. THE INFLATION LUMEN STOPCOCK WAS IN THE OPEN POSITION (INP-7). THE RECOMMENDED VOLUME CAPACITY OF THE BALLOON IS 0.75CC (INP-7). UPON MICROSCOPIC INSPECTION, A WRINKLE WAS NOTED ON THE BALLOON SURFACE (INP-8). DRIED BLOOD WAS NOTED WITHIN THE CATHETER'S BERMAN HOLES (INP-11, INP-12). NO CONDENSATION WAS NOTED WITHIN THE INFLATION LUMEN EXTENSION LINE. LIQUID BLOOD/CONTRAST MEDIA WAS NOTED WITHIN THE INJECTION LUMEN EXTENSION LINE (INP-13). DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED SAMPLE. NO OTHER DAMAGE OR ABNORMALITIES WERE NOTED. BOTH THE SIDES OF THE BALLOON MEASURED APPROXIMATELY 4MM AND WAS WITHIN SPECIFICATIONS PER GRAPHIC OF RADIUS R ATIO LESS THAN OR EQUAL TO 2.0. THE INFLATION LUMEN WAS INJECTED WITH 0.75CC OF AIR USING A LAB INVENTORY CONTROL STROKE SYRINGE. THE BALLOON INFLATED SYMMETRICALLY (ANP-1, ANP-2) AND IT DEFLATED IN LESS THAN 3 SECONDS WHEN THE SYRINGE WAS REMOVED PER SPECIFICATION. NO PULL AWAY WAS NOTED AFTER THE TUG TEST. THE BALLOON WAS PLACED IN WATER AND AIR WAS INJECTED INTO THE INFLATION LUMEN AGAIN. NO LEAK WAS NOTED. THE RUPTURED CATHETER BODY DID NOT RESULT IN DAMAGE TO THE INFLATION LUMEN. THE CATHETER'S INJECTION LUMEN WAS ASPIRATED/FLUSHED, AND AIR WAS NOTED LEAKING FROM THE RUPTURED CATHETER BODY (ANP-3). A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. HOWEVER, THE SPECIFICATIONS WERE NOT MET DURING THE COMPLAINT INVESTIGATION DUE TO THE RUPTURED CATHETER BODY. THE PROBABLE ROOT CAUSE OF THE COMPLAINT IS MANUFACTURING RELATED. CAPA HAS BEEN INITIATED UNDER TELEFLEX'S QUALITY SYSTEM BY THE MANUFACTURING SITE TO FURTHER ADDRESS THIS ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4). OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING POWER INJECTION WHILE IN USE ON A PATIENT WITH A PSI OF 500, THE CATHETER RUPTURED. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED. IT IS UNCLEAR WHAT SITE THE 2ND CATHETER WAS INSERTED AT. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING POWER INJECTION WHILE IN USE ON A PATIENT WITH A PSI OF 500, THE CATHETER RUPTURED. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED. IT IS UNCLEAR WHAT SITE THE 2ND CATHETER WAS INSERTED AT. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508496 CATH PKGD: BERMAN 5 FR 80CM CATHETER, FLOW DIRECTED DYG ARROW INTERNATIONAL LLC IPN917235 16F23C0075 10801902180787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown