BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20774492 · Received November 25, 2024

    Report

    Report Number
    3002601200-2024-00646
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 31, 2024
    Report Date
    December 20, 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

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

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER RETURNED 2 PHOTOS, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTOS SHOW THAT THE SLEEVE STOPPER OF THE PRN IS SEPARATED FROM THE BOTTOM HOUSING, AND THE ASSEMBLY POSITION OF THE BIG END OF THE SLEEVE STOPPER AND THE SHRINKAGE OF THE SHRINK BAND HAVE NO OBVIOUS ABNORMALITIES. 2. DHR/BHR REVIEW LOT# 4052012. 1- THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MARCH 2024, AND PACKAGED AT R240 PACKAGE LINE IN MARCH 2024. 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. 4- THE PRN BATCHES USED IN THIS BATCH OF PRODUCTS ARE 4054127 AND 3083084, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 3. THE RETAINED SAMPLE OF THE COMPLAINT BATCH IS TAKEN FOR THE PULL FORCE TEST OF THE PRN (I.E., TEST THE SEPARATION FORCE BETWEEN THE SLEEVE STOPPER AND THE BOTTOM HOUSING), AND THE TEST RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. PLEASE SEE ATTACHMENT FOR THE TEST REPORT. 4. THE POSSIBLE FACTORS AFFECTING THE SEPARATION FORCE BETWEEN THE SLEEVE STOPPER AND THE BOTTOM HOUSING: RAW MATERIAL FACTORS (INCLUDING THE TENSION OF THE SLEEVE STOPPER, THE DEGREE OF SHRINKAGE OF THE SHRINK BAND), THE ASSEMBLY OF THE PRN, THE FLOW RATE AND PRESSURE DURING THE USE OF THE INDWELLING NEEDLE. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE PHOTOS SHOW A DEFECT OF THE SLEEVE STOPPER OF THE PRN ARE SEPARATED FROM THE BOTTOM HOUSING. THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED AS NO OBVIOUS PRN ASSEMBLY ISSUE CAN BE IDENTIFIED FROM THE PHOTOS, NO ABNORMALITY IS FOUND IN THE RELEVANT TEST OF THE RETAINED SAMPLE, AND NO DEFECTIVE SAMPLE IS RECEIVED FOR FURTHER TEST. THIS IS THE FIRST COMPLAINT ABOUT THE PULL FORCE OF THE PRN IN THIS BATCH, AND THE PLANT WILL CONTINUE TO TRACK THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC SEPARATION OF ADAPTER FROM TUBING. DURING USE, THE HEPARIN CAP AND THE CONNECTION OF THE INTRAVENOUS CATHETER BROKE. THE SAMPLE CAN BE RETURNED, AND PHOTOS ARE AVAILABLE. A GREEN CLAIM IS REQUIRED, A COMPLAINT RESPONSE LETTER IS REQUIRED, AND A RECEIPT IS NOT REQUIRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMAITON PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786862 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052012 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown