BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17726152 · Received September 11, 2023

    Report

    Report Number
    3014704491-2023-00540
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 29, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 29-AUG-2023. H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBERS. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THESE LOTS WERE ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, A SAMPLE WAS RETURNED WHICH DISPLAYED THE REPORTED FOREIGN MATTER. COMPOSITIONAL TESTING OF THE FOREIGN BODY COULD NOT BE PERFORMED DUE TO THE SMALL QUANTITY OF THE MATERIAL. THE SUBSTANCE IS MOST LIKELY DEBRIS FROM THE MANUFACTURING PROCESS AND IS GENERATED AS A RESULT OF A COLLISION BETWEEN THE WHITE ADAPTER PADDLE AND THE MANUFACTURING MACHINERY. TO PREVENT FUTURE OCCURRENCES OUR ENGINEERS HAVE INSTALLED SUCTION DEVICES AT THE STATION OF CONCERN TO COLLECT ANY RESULTING DEBRIS FROM FUTURE COLLISIONS. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3080077. D4. MEDICAL DEVICE EXPIRATION DATE: 12MAY2026. H4. DEVICE MANUFACTURE DATE: 21MAR2023. D4. MEDICAL DEVICE LOT #: 3108378. D4. MEDICAL DEVICE EXPIRATION DATE: 14MAY2026. H4. DEVICE MANUFACTURE DATE: 18APR2023. D4. MEDICAL DEVICE LOT #: 3135087. D4. MEDICAL DEVICE EXPIRATION DATE: 06JUL2026. H4. DEVICE MANUFACTURE DATE: 15MAY2023. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 OF THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD FOREIGN MATTER. THE FOLLOWING WAS TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE NURSE WAS ABOUT TO PUNCTURE THE INDWELLING NEEDLE, WHEN SHE CHECKED THE INDWELLING NEEDLE, SHE FOUND OBVIOUS FOREIGN OBJECTS IN THE PACKAGE (WHITE CONFETTI-LIKE IMPURITIES ON THE HEPARIN CAP).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 OF THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD FOREIGN MATTER. THE FOLLOWING WAS TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE NURSE WAS ABOUT TO PUNCTURE THE INDWELLING NEEDLE, WHEN SHE CHECKED THE INDWELLING NEEDLE, SHE FOUND OBVIOUS FOREIGN OBJECTS IN THE PACKAGE (WHITE CONFETTI-LIKE IMPURITIES ON THE HEPARIN CAP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861366 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown