BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 20130809 · Received September 3, 2024

    Report

    Report Number
    3014704491-2024-00068
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    July 20, 2024
    Report Date
    September 18, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    PMA / PMN Number
    K200891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER RETURNED 3 PHOTOS, NO DEFECTIVE SAMPLE. THE PHOTOS SHOW THAT THE SKU IS 383033, THE BATCH CODE IS 4052072, THE PRODUCT IS BEING INDWELLED IN THE PATIENT, AND THE END CAP IS MISSING. 2. DHR/BHR REVIEW LOT#4052072. 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MARCH 2024, AND PACKAGED AT R240 PACKAGE LINE IN MARCH 2024. WORK ORDER QUANTITY WAS (B)(4). 2-REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR THE END CAP REMOVAL TORQUE TEST. THE TEST RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. PLEASE SEE ATTACHMENT FOR THE TEST REPORT. 4. IN THE ASSEMBLY PROCESS OF THE END CAP, THERE ARE TORQUE AND ASSEMBLY STROKE MONITORING TO ENSURE THAT THE LUER OF THE END CAP CAN BE ASSEMBLED INTO THE PP CONNECTOR TO A CERTAIN DEPTH AND THE THREAD HAS A GOOD FASTENING EFFECT. IF THE END CAP IS NOT IN PLACE, THE EQUIPMENT WILL ALARM AND REMOVE THE PRODUCT. HOWEVER, ALTHOUGH THE END CAP IS FASTENED TO THE PRODUCT DURING ASSEMBLY, IT MAY COME LOOSE IF IT IS VIBRATED DURING TRANSPORTATION. THE IFU OF THE PRODUCT INDICATES: SECURE THE END CAP BEFORE USE. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THE RETURNED PHOTOS SHOW THAT THE PRODUCT IS BEING INDWELLED IN THE PATIENT, AND THE END CAP IS MISSING. SINCE THE DEFECTIVE SAMPLE HAS NOT BEEN RECEIVED, THE RELEVANT TEST CANNOT BE PERFORMED, AND THE USAGE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE END CAP FALLING OFF CANNOT BE DETERMINED, AND THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM CAP WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM CHINESE TO ENGLISH: THE OPERATION AND ANESTHESIA RECOVERY ROOM WERE USED NORMALLY, BUT THE WHITE SCREW CAP FELL OFF DURING TRANSPORTATION. ADDITIONAL INFORMATION PROVIDED: 1. CAUSE SERIOUS HARM? NO. 2. HAS THE PATIENT¿S TREATMENT PLAN BEEN CHANGED? NO. 3. WERE MEDICAL PERSONNEL EXPOSED TO BLOOD/BODY FLUIDS AS A RESULT OF THIS INCIDENT? IF SO, WHAT SCREENING/TREATMENT DID THE MEDICAL STAFF RECEIVE? NO. 4. CAUSE THE PATIENT OR CLINICAL USER TO REQUIRE MEDICAL INTERVENTION TO AVOID HARM? NO 5. ARE OTHER MEASURES BEING TAKEN? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186984 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 4052072 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown