BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18705132 · Received February 14, 2024

    Report

    Report Number
    3002601200-2024-00039
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    January 19, 2024
    Report Date
    March 27, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830282
    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

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER RETURNED 2 PHOTOS, NO DEFECTIVE SAMPLE. THE PHOTO SHOWS THAT THE SLEEVE STOPPER AND SHRINK BAND OF THE PRN ARE BROKEN, AND THE SLEEVE STOPPER AND SHRINK BAND ARE ASSEMBLED IN PLACE. 2. DHR/BHR REVIEW(LOT#3234081): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN AUGUST 2023, AND PACKAGED AT CFS PACKAGE LINE IN AUGUST 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. 4) THE PRN BATCH USED IN THIS BATCH OF PRODUCTS IS 3202502, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO SIMILAR DEFECTS ARE FOUND IN THE PRN. PLEASE SEE ATTACHMENT FOR THE INSPECTION REPORT. 4. ACCORDING TO THE DEFECT STATE OF THE RETURNED SAMPLE, THE PRN IS DAMAGED DUE TO ABNORMAL GRABBING OR COLLISION, AND THE PRN ITSELF IS INTACT. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS RETAINED SAMPLS. ACCORDING TO THE DAMAGED STATE OF SLEEVE STOPPER AND SHRINK BAND SHOWN IN THE RETURNED PHOTOS, THE DEFECTS ARE CAUSED BY ABNORMAL GRASPING OR COLLISION. AS NO DEFECTIVE SAMPLE IS RECEIVED, FURTHER ANALYSIS AND CONFIRMATION CANNOT BE MADE, AND THE ROOT CAUSE CANNOT BE DETERMINED. THIS DEFECT IS AN ISOLATED CASE AND THE PLANT WILL CONTINUE TO PAY ATTENTION TO IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HERAPIN CAP WAS DAMAGED FROM A BD INTIMA-II 24GAX0.75IN PRN SLM NPVC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2024, THE HEPARIN CAP WAS WIPED WITH AN ALCOHOL SWAB PRIOR TO PREPARING FOR AN INFUSION, AND JUST AFTER WIPING IT, THE INSIDE OF THE HEPARIN CAP WAS FOUND TO BE FLARED OUT AND STRUCTURALLY ALTERED, AND UPON CLOSER INSPECTION, THE PERIMETER OF THE FLAT SURFACE OF THE HEPARIN CAP HAD BEEN TORN AND THERE WERE TWO OR THREE SMALL HOLES IN THE HEPARIN CAP, AND THE HEPARIN CAP WAS NO LONGER AIRTIGHT, AND IT WAS BEING REPLACED WITH AN AIRTIGHT IV NEEDLE TO BE USED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424435 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3234081 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown