BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 5 FR 80CM

    MDR report key: 17425052 · Received July 31, 2023

    Report

    Report Number
    3010532612-2023-00451
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    July 11, 2023
    Report Date
    July 12, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DYG
    UDI-DI
    10801902180787
    PMA / PMN Number
    K892530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT OF CATHETER BODY RUPTURED IN USE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED A 5FR. 80CM BERMAN CATHETER WITH THE ORIGINAL PACKAGING POUCH (INP-3, INP-7) FOR INVESTIGATION. THE SAMPLE WAS RETURNED IN A CARDBOARD BOX 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 89.1CM TO 89.6CM FROM THE DISTAL TIP OF THE CATHETER (INP-11, INP-12). THE SUPPLIED CONTROL STROKE SYRINGE WAS NOTED CONNECTED TO THE INFLATION LUMEN STOPCOCK; NO DAMAGE OR ABNORMALITIES WERE NOTED TO THE RETURNED SYRINGE (INP-8). THE INFLATION LUMEN STOPCOCK WAS IN THE OPEN POSITION (INP-8). THE RECOMMENDED VOLUME CAPACITY OF THE BALLOON IS 0.75CC (INP-9). UPON MICROSCOPIC INSPECTION, THE BALLOON APPEARED TYPICAL; NO DAMAGE OR ABNORMALITIES WERE NOTED TO THE BALLOON (INP-10). DRIED BLOOD WAS NOTED WITHIN THE BERMAN HOLES (INP-13, INP-14). NO CONDENSATION WAS NOTED WITHIN THE INFLATION LUMEN EXTENSION LINE. DRIED CONTRAST MEDIA WAS NO TED WITHIN THE INJECTION LUMEN EXTENSION LINE (INP-15). DRIED BLOOD/CONTRAST MEDIA WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED SAMPLE. NO OTHER DAMAGE OR ABNORMALITIES WERE NOTED. THE INFLATION LUMEN WAS INJECTED WITH 0.75CC OF AIR USING THE RETURNED CONTROL STROKE SYRINGE. THE BALLOON INFLATED SYMMETRICALLY (ANP-1, ANP-2). BOTH THE SIDES OF THE BALLOON MEASURED APPROXIMATELY 4MM EACH. THE BALLOON DID MEET SPECIFICATIONS PER GRAPHIC OF RADIUS RATIO LESS THAN OR EQUAL TO 2.0. THE INFLATION LUMEN WAS INJECTED WITH 0.75CC OF AIR USING THE RETURNED CONTROL STROKE SYRINGE. THE BALLOON INFLATED SYMMETRICALLY (ANP-1, ANP-2). THE BALLOON 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 WAS MANUFACTURING RELATED. A CAPA HAS BEEN INITIATED TO ADDRESS THE ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE. ADDITIONAL INFORMATION RECEIVED ON 01 AUGUST 2023 STATES THAT ALL 3 CATHETERS WERE INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "STABLE". ADDITIONAL INFORMATION RECEIVED ON 30 AUG 2023 STATES THAT "ALL THREE CATHETERS RUPTURED DURING INJECTION, AT THE SAME AREA, ON THE CATHETER, JUST BELOW THE HUB. THE INJECTIONS WERE ALL THE SAME SETTINGS."

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CATHETER "RUPTURED DURING A CASE". AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED, HOWEVER THE SAME ISSUE OCCURRED. A 3RD CATHETER WAS THEN INSERTED AND AGAIN THE SAME ISSUE OCCURRED. 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. SEE ASSOCIATED MDRS #3010532612-2023-00449 AND #3010532612-2023-00450.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CATHETER "RUPTURED DURING A CASE". AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED, HOWEVER THE SAME ISSUE OCCURRED. A 3RD CATHETER WAS THEN INSERTED AND AGAIN THE SAME ISSUE OCCURRED. 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. SEE ASSOCIATED MDRS #3010532612-2023-00449 AND #3010532612-2023-00450.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660778 CATH PKGD: BERMAN 5 FR 80CM CATHETER, FLOW DIRECTED DYG ARROW INTERNATIONAL LLC 16F23C0003 10801902180787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown