BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO SURFLO INTRAVENOUS CATHETER

    MDR report key: 22058037 · Received May 20, 2025

    Report

    Report Number
    3003902955-2025-00025
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 20, 2025
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FOZ
    PMA / PMN Number
    K133280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: BERNESE MOUNTAIN DOG. A2: AGE OR DATE OF BIRTH: 1.5 YEARS OLD. A3A: SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: NOT APPLICABLE FOR ANIMAL USE. A6: RACE: NOT APPLICABLE FOR ANIMAL USE. D4: LOT #: 220814SD, 230506SD & 230507SD D4: EXPIRATION DATE: 31-JUL-2027, 30-APR-2028, & 30-APR-2028. D4: UDI: NOT APPLICABLE. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: OFFICE MANAGER. H4: DEVICE MANUFACTURE DATE: 14-AUG-2022, 6-MAY-2023, & 7-MAY-2023. THE ACTUAL SAMPLE WAS NOT AVAILABLE. INSTEAD, A REFERENCE PHOTO WAS RECEIVED. THE PROXIMAL END OF THE BROKEN CATHETER HAS TRACES OF BLOOD. THE DEFECTS THAT COULD LEAD TO THE COMPLAINT CANNOT BE CONFIRMED THROUGH THE PHOTO. RETENTION SAMPLES WERE VISUALLY INSPECTED AND FOUND TO BE FREE OF ANY CATHETER DAMAGE THAT COULD HAVE CAUSED THE COMPLAINT. THE SAMPLES UNDERWENT A CATHETER TUBE AND CATHETER HUB FITTING FORCE TEST. ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. THERE WAS NO ISSUED NONCONFORMITY REPORT RELATED TO HUMAN ERROR DURING LOT PRODUCTION. THE REPORTED ITEM CODE IS PRODUCED AT SR4, A SEMI-AUTOMATED LINE. DURING CATHETER ASSEMBLY, THE CATHETER IS CUT TO THE DESIRED LENGTH, AND THE FLANGE IS FORMED AND PRESSED INTO THE CATHETER HUB. THE CATHETER'S TIP IS THEN FORMED. BASED ON THE SR MACHINE DOWNTIME HISTORY, THERE ARE NO RELATED MACHINE TROUBLES THAT COULD HAVE CAUSED THE COMPLAINT. WE PERFORM INITIAL QUALITY CONFIRMATION THROUGH VISUAL INSPECTION AND FUNCTIONAL TESTS BEFORE MASS PRODUCTION. DURING VISUAL INSPECTION 1, ALL PRODUCTS ARE CHECKED FOR DAMAGED OR DEFORMED CATHETER TUBE CONDITION. THE CATHETER TUBE AND CATHETER HUB FITTING TEST IS CONDUCTED DURING THE PRODUCTION PROCESS. THE RECORDS SHOWED THAT THE RESULTS WERE PASSED. VISUAL IN-PROCESS INSPECTIONS WERE CONDUCTED DURING 100% VISUAL INSPECTIONS TO CHECK THE CATHETER TUBE CONDITION. BEFORE SHIPMENT, WE HAVE AN OUTGOING INSPECTION TO CHECK THE OVERALL CONDITION OF THE PRODUCT. THE CATHETER TUBE UNDERGO INCOMING INSPECTION WHICH INCLUDES VISUAL INSPECTION AND VERIFICATION OF THE CERTIFICATE OF ANALYSIS ACCORDING TO THE MATERIAL SPECIFICATION. FROM THE PREVIOUS TWO FISCAL YEARS TO THE PRESENT, WE RECEIVED A TOTAL OF 19 OUT OF 31 (58%) COMPLAINTS FOR THE SAME ISSUE THAT HAVE OCCURRED DURING USAGE. THE RESULT OF THE INVESTIGATION SHOWED THAT THERE WAS NO ATTRIBUTABLE CAUSE NOTED RELATED TO OUR PRODUCT OR THE MANUFACTURING PROCESS. BASED ON THE RESULTS OF OUR INVESTIGATION, THERE IS NO EVIDENCE THAT THERE WAS A PRE-EXISTING DEFECT WITH THE DEVICE RELATED TO EITHER THE MATERIALS OR THE MANUFACTURING PROCESS. THE DEVICE FAILURE IS CONFIRMED ON THE SAMPLE. HOWEVER, THE CATHETER WAS PLACED INTO THE VEIN SUCCESSFULLY. THE CATHETER TUBE CONDITION OF OUR RETENTION SAMPLES WAS VISUALLY GOOD AND PASSED THE RELATED FUNCTIONAL TESTS. THE LOT HISTORY FILE WAS CHECKED, AND NO NONCONFORMITY WAS NOTED THAT MAY RESULT IN CATHETER TUBE BREAKAGE. THE BROKEN CATHETER TUBE WAS FOUND DURING THE REMOVAL PROCESS INDICATING THAT THE DEVICE WAS SUCCESSFULLY INSERTED. OUR CATHETER TUBE HAS HIGH TENSILE STRENGTH AND DOES NOT BREAK EASILY EVEN WHEN A STRONG FORCE IS APPLIED. THERE IS NO EVIDENCE THAT THERE WAS A PRE-EXISTING DEFECT WITH THE DEVICE RELATED TO EITHER THE MATERIALS OR THE MANUFACTURING PROCESS. A REVIEW OF THE PRODUCT'S LOT HISTORY FILE REVEALED NO ISSUES THAT WERE ENCOUNTERED DURING THE PRODUCTION OF THE REPORTED LOT. WE HAVE ROUTINE INSPECTIONS TO CHECK THE CONDITION OF THE PRODUCTS. WE PERFORM AN OUTGOING INSPECTION PRIOR TO SHIPMENT TO ENSURE THE OVERALL CONDITION OF THE CATHETERS. THEREFORE, OUR PROCESS IS ASSURED. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO (PHILIPPINES) CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT MOUNTAIN DOG, 1.5 YEARS OLD, PRESENTED ON (B)(6) FOR A BITE WOUND. A SUR-VET 18G 1.25 CATHETER WAS INSTALLED FOR SEDATION. THE SERIAL NUMBER OF THE CATHETER CANNOT BE CONFIRMED WITH CERTAINTY AS THE PACKAGING WAS DISCARDED, BUT THREE SERIAL NUMBERS WERE NOTED IN THE STORAGE AREA: (B)(6). THE TECHNICIAN DOCUMENTED THE ENTIRE PROCEDURE, WHICH WENT WELL OVERALL, EXCEPT FOR SOME MOVEMENTS OF THE DOG'S PAW FOLLOWING THE INSTALLATION AND BEFORE THE CATHETER WAS SECURED. THE CATHETER WAS SECURED, AND THE PROCEDURE WAS PERFORMED SUCCESSFULLY. DURING REMOVAL, THE TECHNICIAN FELT SLIGHT RESISTANCE AND THEN NOTICED THAT APPROXIMATELY 1 CM OF THE CATHETER WAS MISSING WHEN REMOVED. ATTEMPTS TO LOCATE THE MISSING PIECE USING X-RAYS FOLLOWING THE PROCEDURE WERE UNSUCCESSFUL. A SPECIALIST RE-EVALUATED THE X-RAYS, AND A CT SCAN WAS PERFORMED THE NEXT DAY AT THE ESTABLISHMENT'S EXPENSE. THE CT SCAN REVEALED THE PRESENCE OF THE CATHETER FRAGMENT IN THE PULMONARY ARTERY OF THE PATIENT'S ACCESSORY LOBE. FOR NOW, THE PATIENT IS DOING WELL, AND THE CLIENTS ARE AWARE OF THE FUTURE INHERENT RISKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51814 TERUMO SURFLO INTRAVENOUS CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ TERUMO PHILIPPINES CORPORATION SROX1832V

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Unknown