BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10429385 · Received August 20, 2020

    Report

    Report Number
    3006948883-2020-00360
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    July 21, 2020
    Report Date
    September 28, 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

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9170855. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM NEEDLE BROKE OFF DURING USE WHEN IT WAS INSERTED INTO THE CHILD PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE PATIENT WAS ADMITTED TO HOSPITAL ON JULY 19, 2020 BECAUSE OF "REPEATED PHARYNGEAL PAIN AND MOUTH OPENING BREATHING AT NIGHT FOR 3 MONTHS". THE DIAGNOSIS WAS CHRONIC TONSILLITIS. AFTER ADMISSION, INTRAVENOUS INFUSION WAS GIVEN. IN ORDER TO REDUCE THE NUMBER OF PUNCTURES AND PROTECT THE BLOOD VESSELS, CLOSED INTRAVENOUS INDWELLING NEEDLE WAS USED FOR INTRAVENOUS INFUSION.ON 2020-07-21 WHEN PERFORMING INDWELLING NEEDLE PUNCTURE FOR THE CHILD, THE TROCAR WAS BROKEN WHEN THE INDWELLING NEEDLE WAS INSERTED, RESULTING IN FAILURE OF PUNCTURE. AFTER EXPLAINING TO THE FAMILY OF THE CHILD PATIENT, A NEW INDWELLING NEEDLE SHOULD BE REPLACED IMMEDIATELY TO COMPLETE THE PUNCTURE, CAUSING PAIN FOR THE CHILD TO UNDERGO A SECOND 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 NEEDLE BROKE OFF DURING USE WHEN IT WAS INSERTED INTO THE CHILD PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2020 BECAUSE OF "REPEATED PHARYNGEAL PAIN AND MOUTH OPENING BREATHING AT NIGHT FOR 3 MONTHS". THE DIAGNOSIS WAS CHRONIC TONSILLITIS. AFTER ADMISSION, INTRAVENOUS INFUSION WAS GIVEN. IN ORDER TO REDUCE THE NUMBER OF PUNCTURES AND PROTECT THE BLOOD VESSELS, CLOSED INTRAVENOUS INDWELLING NEEDLE WAS USED FOR INTRAVENOUS INFUSION. ON (B)(6) 2020 WHEN PERFORMING INDWELLING NEEDLE PUNCTURE FOR THE CHILD, THE TROCAR WAS BROKEN WHEN THE INDWELLING NEEDLE WAS INSERTED, RESULTING IN FAILURE OF PUNCTURE. AFTER EXPLAINING TO THE FAMILY OF THE CHILD PATIENT, A NEW INDWELLING NEEDLE SHOULD BE REPLACED IMMEDIATELY TO COMPLETE THE PUNCTURE, CAUSING PAIN FOR THE CHILD TO UNDERGO A SECOND PUNCTURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899673 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9170855

    Patients

    Seq Age Sex Outcome Treatment
    1 Other