BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18292270 · Received December 8, 2023

    Report

    Report Number
    3014704491-2023-00802
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    November 8, 2023
    Report Date
    February 13, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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. DHR/BHR REVIEW (LOT#: 3080088): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2023, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 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. AMONG THEM, THE PRN TORQUES MEET THE OUTGOING INSPECTION REQUIREMENT. 3) REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4) THE PRN BATCH USED IN THIS BATCH OF PRODUCTS IS 3083068, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR PRN REMOVAL TORQUE TEST AND PRN PULL FORCE TEST (I.E., TEST THE SEPARATION FORCE BETWEEN THE SLEEVE STOPPER AND THE BOTTOM HOUSING), AND THE TEST RESULTS ARE ALL WITHIN THE PRODUCT SPECIFICATIONS. CONCLUSION(S): AS NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, THE STATUS OF THE PRN COMING APART AND FALLING OFF CANNOT BE IDENTIFIED, AND THE USAGE OF THE INDWELLING NEEDLE IS UNKNOWN, SO THE ROOT CAUSE OF THE DEFECT CANNOT BE CONFIRMED.

    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 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM CAP CAME LOOSE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; CLINICAL NURSE'S HEPARIN CAP CAME APART AND FELL OFF DURING INDWELLING NEEDLE SEALING. REPUNCTURE WITH A NEW CLOSED IV INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205861 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080088 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown