BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 16064928 · Received December 28, 2022

    Report

    Report Number
    3014704491-2022-00713
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    November 21, 2022
    Report Date
    January 17, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2053286. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    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 THE BD INTIMA II¿ IV CATHETER PRN ADAPTER EXPERIENCED LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE WOMAN WAS ADMITTED TO THE HOSPITAL DUE TO IRREGULAR ABDOMINAL PAIN IN THE SCARRED UTERUS. A CESAREAN SECTION WAS SCHEDULED. THE PREOPERATIVE PREPARATION WAS PERFORMED AT 13.20. THE INTRAVENOUS INDWELLING NEEDLE WAS USED TO ESTABLISH A VENOUS CHANNEL. AFTER THE PUNCTURE WAS SUCCESSFUL, THE INFUSION SET AND RS500ML WERE CONNECTED, AND THE VENOUS INDWELLING NEEDLE WAS FOUND IF FLUID LEAKS AT THE CONNECTION, REPLACE IT IMMEDIATELY, RE-PUNCTURE, AND ESTABLISH A NEW VENOUS ACCESS. CAUSES THE SECOND PUNCTURE OF THE PARTURIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA II¿ IV CATHETER PRN ADAPTER EXPERIENCED LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE WOMAN WAS ADMITTED TO THE HOSPITAL DUE TO IRREGULAR ABDOMINAL PAIN IN THE SCARRED UTERUS. A CESAREAN SECTION WAS SCHEDULED. THE PREOPERATIVE PREPARATION WAS PERFORMED AT 13.20. THE INTRAVENOUS INDWELLING NEEDLE WAS USED TO ESTABLISH A VENOUS CHANNEL. AFTER THE PUNCTURE WAS SUCCESSFUL, THE INFUSION SET AND RS500ML WERE CONNECTED, AND THE VENOUS INDWELLING NEEDLE WAS FOUND IF FLUID LEAKS AT THE CONNECTION, REPLACE IT IMMEDIATELY, RE-PUNCTURE, AND ESTABLISH A NEW VENOUS ACCESS. CAUSES THE SECOND PUNCTURE OF THE PARTURIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2093438 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2053286

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown