BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10314403 · Received July 23, 2020

    Report

    Report Number
    3006948883-2020-00310
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    June 20, 2020
    Report Date
    August 12, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141723. 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, VISUAL EXAMINATION WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT. THE RETENTION SAMPLES WERE FOUND TO BE FREE OF ANY ABNORMALITIES OR DEFECTS THAT COULD CONTRIBUTE TO A BROKEN CANNULA. 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 H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED A LOOSE NEEDLE WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHILDREN ADMITTED BECAUSE OF "UPPER RESPIRATORY INFECTION", AFTER ADMISSION EXAMINATION DOUBLE LUNG BREATH SOUNDS CRUDE, THE DOCTOR'S ADVICE TO COOL THE ANTI-INFLAMMATORY DRUGS SUCH AS SYMPTOMATIC TREATMENT, PRESCRIBED GIVEN INTRAVENOUS INFUSION, TO REDUCE CHILDREN WITH PIERCING PAIN FOR MANY TIMES, THE FAMILY AGREED TO GIVE NEEDLE INJECTION, OPERATION FOUND NEEDLE CORE IS LOOSE, NOT OPERATION, CHANGE IN TIME, DID NOT HAVE A NEGATIVE EFFECT. FOR IN WHAT WAY IS THE NEEDLE LOOSE: IT IS THE NEEDLE DEFLECTING DURING ATTEMPTED PUNCTURE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II CLOSED IV CATHETER SYSTEM EXPERIENCED A LOOSE NEEDLE WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHILDREN ADMITTED BECAUSE OF "UPPER RESPIRATORY INFECTION", AFTER ADMISSION EXAMINATION DOUBLE LUNG BREATH SOUNDS CRUDE, THE DOCTOR'S ADVICE TO COOL THE ANTI-INFLAMMATORY DRUGS SUCH AS SYMPTOMATIC TREATMENT, PRESCRIBED GIVEN INTRAVENOUS INFUSION, TO REDUCE CHILDREN WITH PIERCING PAIN FOR MANY TIMES, THE FAMILY AGREED TO GIVE NEEDLE INJECTION, OPERATION FOUND NEEDLE CORE IS LOOSE, NOT OPERATION, CHANGE IN TIME, DID NOT HAVE A NEGATIVE EFFECT. FOR IN WHAT WAY IS THE NEEDLE LOOSE: IT IS THE NEEDLE DEFLECTING DURING ATTEMPTED PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782318 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9141723

    Patients

    Seq Age Sex Outcome Treatment
    1 Other