BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10052123 · Received May 13, 2020

    Report

    Report Number
    3006948883-2020-00184
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    April 17, 2020
    Report Date
    June 22, 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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141678. 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 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 AFTER INSERTION BLOOD LEAKAGE WAS DISCOVERED AT THE CONNECTION OF INDWELLING NEEDLE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT, FEMALE, 56 YEARS OLD, WAS ADMITTED TO THE HOSPITAL AT 07:54 ON (B)(6) 2020 DUE TO REPEATED COUGH AND SPUTUM ACCOMPANIED BY CHEST TIGHTNESS AND SUFFOCATION, WHICH HAD BEEN AGGRAVATED FOR MORE THAN 10 DAYS. AT 12:10 ON (B)(6) 2020, THE INTRAVENOUS INDWELLING NEEDLE PUNCTURE WAS PERFORMED FOR THE PATIENT. AT 12:12, BLOOD LEAKAGE WAS FOUND IN THE CONNECTOR OF THE INDWELLING NEEDLE AFTER SUCCESSFUL PUNCTURING, WHICH WAS PULLED OUT IMMEDIATELY. AT 12:14, THE INDWELLING NEEDLE WAS REPLACED. NO BLOOD LEAKAGE OCCURRED IN THE SUCCESSFUL PUNCTURING, AND THE INFUSION WAS SUCCESSFULLY COMPLETED, IT WAS RESULTED IN A SECOND PUNCTURING FOR THE PATIENT.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: THE PATIENTS BIRTHDAY WAS NOT PROVIDED, THE YEAR HAS BEEN CALCULATED BASED OFF AGE. 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 · 1

    IT WAS REPORTED THAT AFTER INSERTION BLOOD LEAKAGE WAS DISCOVERED AT THE CONNECTION OF INDWELLING NEEDLE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PATIENT, FEMALE, (B)(6) YEARS OLD, WAS ADMITTED TO THE HOSPITAL AT 07:54 ON (B)(6) 2020 DUE TO REPEATED COUGH AND SPUTUM ACCOMPANIED BY CHEST TIGHTNESS AND SUFFOCATION, WHICH HAD BEEN AGGRAVATED FOR MORE THAN 10 DAYS. AT 12:10 ON (B)(6) 2020, THE INTRAVENOUS INDWELLING NEEDLE PUNCTURE WAS PERFORMED FOR THE PATIENT. AT 12:12, BLOOD LEAKAGE WAS FOUND IN THE CONNECTOR OF THE INDWELLING NEEDLE AFTER SUCCESSFUL PUNCTURING, WHICH WAS PULLED OUT IMMEDIATELY. AT 12:14, THE INDWELLING NEEDLE WAS REPLACED. NO BLOOD LEAKAGE OCCURRED IN THE SUCCESSFUL PUNCTURING, AND THE INFUSION WAS SUCCESSFULLY COMPLETED, IT WAS RESULTED IN A SECOND PUNCTURING FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518296 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9141678

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other