BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18345607 · Received December 18, 2023

    Report

    Report Number
    3014704491-2023-00829
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    November 10, 2023
    Report Date
    March 14, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    PMA / PMN Number
    NA
    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. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED, AND BASED ON THE LIMITED INFORMATION, WE ARE UNABLE TO CONFIRM WHETHER THE SCREW CAP REFERS TO THE PRN OR THE END CAP, AND ITS CONNECTION STATUS TO THE PP CONNECTOR. 2. DHR/BHR REVIEW(LOT#3171583): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JULY 2023, AND PACKAGED AT R240 PACKAGE LINE IN JULY 2023. WORK ORDER QUANTITY WAS (B)(4) EA. 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 45PSI LEAKAGE TEST, AND NO LEAKAGE IS FOUND IN THE SAMPLE. PRN TORQUE TEST AND END CAP TORQUE TEST ARE CARRIED OUT ON THE SAMPLE, AND THE TEST RESULTS ARE ALL WITHIN THE PRODUCT SPECIFICATIONS. PLEASE SEE THE ATTACHED TEST REPORTS. 4. POSSIBLE CAUSE OF LEAKAGE AFTER TIGHTENING: MALOCCLUSION OCCURS, I.E. THE LUER OF THE PRN OR END CAP IS NOT OCCLUDED CORRECTLY WITH THE LUER OF THE PP CONNECTOR. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND IN PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. THE ROOT CAUSE OF THE LEAKAGE FROM THE MOUTH THE SCREW CAP AFTER TIGHTENING CANNOT BE DETERMINED BECAUSE THE DEFECTIVE SAMPLE IS NOT RECEIVED FOR ANALYSIS AND CONFIRMATION. CUSTOMER STATED THE DEVICE WAS USED TWICE PRIOR TO THE DISCOVERY OF THE LEAK. H3 OTHER TEXT : SEE NARRATIVE.

    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

    DEVICE WAS USED FOR MULTIPLE PUNCTURES. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; 23.11.10, BECAUSE THE PATIENT'S PHYSICAL CONDITION IS NOT GOOD, FOLLOW THE DOCTOR'S ORDERS TO GIVE INTRAVENOUS INFUSION TREATMENT, THE NURSE GAVE THE PATIENT PATIENT TO USE THE CLOSED-TYPE INTRAVENOUS INDWELLING NEEDLE FOR INDWELLING NEEDLE PUNCTURE, OPEN THE INFUSION TO SEE THE CLOSED-TYPE INTRAVENOUS INDWELLING NEEDLE HAS BEEN TIGHTENED THE SCREW CAP MOUTH IS STILL OOZING, IMMEDIATELY REMOVED AND REPLACED WITH A NEW CLOSED-TYPE INTRAVENOUS INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68201 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3171583 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown