BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN

    MDR report key: 18329091 · Received December 14, 2023

    Report

    Report Number
    3006948883-2023-00128
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 7, 2023
    Report Date
    February 13, 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

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

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW(LOT#1050972): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN FEBRUARY 2021, AND PACKAGED AT CFS PACKAGE LINE IN FEBRUARY 2021. 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. 2. NO ACTUAL SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE PLANT HAS NO RELEVANT TEST FOR THIS COMPLAINT. 4. AS FOR THE DISLODGMENT OF THE INDWELLING NEEDLE , THAT IS, THE CATHETER BACKING OUT OF THE VEIN, IT IS MAINLY APPLIED BY THE NURSE. IT IS RECOMMENDED TO HOLD THE FILM WITHOUT TENSION WHEN APPLYING, ALIGN THE POSITION, PINCH THE PERIPHERY OF THE CATHETER HUB, AND PRESS THE WHOLE PIECE FROM THE INSIDE OUT. PLEASE SEE THE ATTACHMENT FOR THE APPLICATION VIEW. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THE INDWELLING NEEDLE IS FIXED BY APPLYING, AND EXTERNAL PULLING WILL CAUSE THE INDWELLING NEEDLE TO FALL OFF. IT CANNOT BE DETERMINED THAT THE COMPLAINT IS RELATED TO THE PLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II 24GAX0.75IN PRN CATHETER BACKED OUT OF THE VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM CHINESE TO ENGLISH: "THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2023, AND WAS GIVEN AN IV INDWELLING NEEDLE PUNCTURE AS PRESCRIBED, AND WAS INATTENTIVE DURING PLAY, WHICH RESULTED IN DISLODGMENT OF THE INDWELLING NEEDLE."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327565 BD INTIMA-II 24GAX0.75IN PRN INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 1050972 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown