BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15585207 · Received October 12, 2022

    Report

    Report Number
    3014704491-2022-00483
    Event Type
    Injury
    Date Received
    October 12, 2022
    Date of Event
    September 19, 2022
    Report Date
    October 13, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830282
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER E-MAIL: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2053245. 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. NEITHER A SAMPLE OR COPIES OF THE REPORTED X-RAYS COULD BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, VISUAL ANALYSIS WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RETAINED DEVICES WERE FOUND TO BE FREE OF ANY DAMAGE OR OTHER ABNORMALITIES AND CLEARLY DISPLAYED THE IMPERMEABLE MARKINGS ON THE CATHETER TUBING. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS ACCIDENTALLY CUT OFF WHILE SHAVING THE PATIENT'S HEAD, WITH PART OF THE CATHETER REMAINING IN THE PATIENT. AN ULTRASOUND AND FLUOROSCOPY WERE PERFORMED TO LOCATE THE BROKEN PIECE. NO FURTHER INFORMATION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN THE HOSPITAL USES THE PRODUCT FOR THE CHILD'S HEAD, IT NEEDS TO SHAVE THE CHILD'S HAIR, AND IT IS FOUND THAT THE PRODUCT¿S CATHETER TUBING. AFTER USING ALL THE ULTRASOUND OF THE HOSPITAL TO FIND THE BROKEN TUBE, IT IS NOT FOUND THAT THE 6 KINDS OF OPAQUE X-RAY RAYS ADVERTISED BY BD, AND IT IS SUSPECTED THAT THE PRODUCT DOES NOT HAVE 6 KINDS OF X-RAY RAYS, WHICH NEEDS TO BE SOLVED AS SOON AS POSSIBLE... AFTER COMMUNICATING WITH THE CUSTOMER, THE CUSTOMER SAID THAT BECAUSE IT PLACED A TUBE ON THE HEAD OF A CHILD, IT WAS ACCIDENTALLY CUT OFF DURING SHAVING, AND THEN HE URGENTLY NOTIFIED THE DOCTOR. AFTER ULTRASOUND AND FLUOROSCOPY, THERE WAS NO BROKEN TUBE TEMPORARILY. LATER, OTHER DOCTORS REPORTED THAT THE DEPARTMENT HAD PRECISION INSTRUMENTS PLACED BY OTHER MANUFACTURERS, SO THE OPERATION WAS SUCCESSFUL IN POSITIONING AND GRASPING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS ACCIDENTALLY CUT OFF WHILE SHAVING THE PATIENT'S HEAD, WITH PART OF THE CATHETER REMAINING IN THE PATIENT. AN ULTRASOUND AND FLUOROSCOPY WERE PERFORMED TO LOCATE THE BROKEN PIECE. NO FURTHER INFORMATION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN THE HOSPITAL USES THE PRODUCT FOR THE CHILD'S HEAD, IT NEEDS TO SHAVE THE CHILD'S HAIR, AND IT IS FOUND THAT THE PRODUCT¿S CATHETER TUBING. AFTER USING ALL THE ULTRASOUND OF THE HOSPITAL TO FIND THE BROKEN TUBE, IT IS NOT FOUND THAT THE 6 KINDS OF OPAQUE X-RAY RAYS ADVERTISED BY BD, AND IT IS SUSPECTED THAT THE PRODUCT DOES NOT HAVE 6 KINDS OF X-RAY RAYS, WHICH NEEDS TO BE SOLVED AS SOON AS POSSIBLE... AFTER COMMUNICATING WITH THE CUSTOMER, THE CUSTOMER SAID THAT BECAUSE IT PLACED A TUBE ON THE HEAD OF A CHILD, IT WAS ACCIDENTALLY CUT OFF DURING SHAVING, AND THEN HE URGENTLY NOTIFIED THE DOCTOR. AFTER ULTRASOUND AND FLUOROSCOPY, THERE WAS NO BROKEN TUBE TEMPORARILY. LATER, OTHER DOCTORS REPORTED THAT THE DEPARTMENT HAD PRECISION INSTRUMENTS PLACED BY OTHER MANUFACTURERS, SO THE OPERATION WAS SUCCESSFUL IN POSITIONING AND GRASPING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2876467 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2053245 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention