BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20418975 · Received October 10, 2024

    Report

    Report Number
    3002601200-2024-00515
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    March 30, 2024
    Report Date
    October 23, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    PMA / PMN Number
    UNK
    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#3262379. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN (B)(6) 2023 AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN (B)(6) 2023. 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. 4-THE CANNULA BATCHES USED IN THIS BATCH OF PRODUCTS ARE 3142091 AND 3142092, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELATED FUNCTIONAL TEST: RIGIDITY AND TOUGHNESS TEST OF THE CANNULA. THE TEST RESULTS ARE WITHIN THE PRODUCT SPECIFICATIONS. PLEASE REFER TO THE ATTACHMENT FOR TEST REPORTS. 4. ACCORDING TO THE EXPERIENCE OF PREVIOUS MARKET VISITS, IT IS RECOMMENDED THAT: INSERT THE NEEDLE AND CATHETER AT 15°~30° WITH THE BEVEL OF THE NEEDLE TIP UPWARDS, AND AFTER SEEING THE BLOOD RETURN, LOWER THE ANGLE TO 5°~10° TO CONTINUE SEND THE NEEDLE AND CATHETER. 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. SINCE THE DEFECTIVE SAMPLE IS NOT RETURNED, FURTHER TEST CANNOT BE PERFORMED, AND THE SKIN AND VEIN CONDITIONS OF THE PATIENT AND THE PUNCTURE TECHNIQUE OF THE NURSE ARE UNKNOWN, THE ROOT CAUSE OF THE FRACTURE OF THE NEEDLE CANNOT BE DETERMINED.

    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 NPVC NEEDLE BROKEN. TODAY, DURING THE PROCESS OF GIVING AN INDWELLING NEEDLE TO A PATIENT, WHEN WITHDRAWING THE NEEDLE CORE, THE CORE BROKE, IMMEDIATELY TRY TO TAKE OUT THE REMAINING CORE, CALM THE PATIENT, AND DO A GOOD JOB OF EXPLANATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956616 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3262379 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown