BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WITH WINGS

    MDR report key: 12236576 · Received July 28, 2021

    Report

    Report Number
    1710034-2021-00615
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    June 14, 2021
    Report Date
    August 25, 2021
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 0223143, D.4. MEDICAL DEVICE EXPIRATION DATE: 7/31/2023, H.4. DEVICE MANUFACTURE DATE: 8/10/2020. D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/14/2021. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED ONE CATHETER ADAPTER ASSEMBLY AND ONE SEALED UNUSED UNIT. IT WAS REPORTED THAT PHLEBITIS AND AN INFECTION OCCURRED. AN INFECTION MAY OCCUR DUE TO IMPROPER STERILITY. PHLEBITIS, OR INFLAMMATION OF THE VEIN, MAY OCCUR DUE TO IRRITATION OR DAMAGE TO THE VEIN. THE UNOPENED UNIT WAS INSPECTED FOR ANY DEFECTS OR GAPS IN THE SEAL THAT COULD AFFECT STERILITY. NO DEFECTS TO THE SEAL WERE OBSERVED. ADDITIONALLY, THE SEAL WIDTH WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION. A PACKAGE LEAK TEST WAS PERFORMED AND NO LEAKAGE WAS OBSERVED. STERILIZATION IS PERFORMED ON THE PRODUCT PRIOR TO SHIPPING AND IS CONFIRMED WITH BIOLOGICAL TESTING. BIOLOGICAL INDICATORS TESTED WITHIN THE SPECIFICATION. AS THE PACKAGE FOR THE USED UNIT WAS NOT RECEIVED, IT COULD NOT BE ASSESSED FOR A PROPER/FULL SEAL. INFECTIONS MAY BE A RESULT OF POOR ASEPTIC TECHNIQUE OR INTRODUCTION OF BACTERIA DURING HANDLING OF THE DEVICE. INFLAMMATION OF THE VEIN MAY HAVE ALSO BEEN A RESULT OF A DULL, BURRED, OR DAMAGED NEEDLE OR CATHETER TIPS. THE CATHETER AND NEEDLE TIP OF THE UNUSED UNIT WERE INSPECTED FOR DAMAGE. BOTH WERE FOUND TO BE WITHIN SPECIFICATION. THE USED CATHETER WAS ALSO INSPECTED AND FOUND TO BE WITHIN SPECIFICATION. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. BD WAS UNABLE TO CONFIRM THE REPORTED DEFECT. THE DHR FOR LOT 0223143 HAS BEEN REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. THE BHR¿S FOR LOTS 0223143 HAVE BEEN REVIEWED. BHR BATCHES 220U234 AND 520U235. TWO RELATED QUALITY ISSUES WERE FOUND: QN¿S (B)(4). BIOLOGICAL INDICATORS TESTED WITHIN THE SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED PHLEBITIS WHEN THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WITH WINGS WAS USED ON THEM. AS A RESULT, THEY REMAINED HOSPITALIZED FOR A LONGER PERIOD WHILE UNDER ANTICOAGULANT PREVENTIVE TREATMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "PUNCTURE SITE INFLAMED AND SWOLLEN ON THE PATH OF THE VEIN. CLINICAL CONSEQUENCES: PHLEBITIS, INFECTION." "THIS DECLARATION WAS MADE BECAUSE THIS COMPLICATION HAS BEEN FREQUENT FOR SEVERAL MONTHS." "THE PATIENT WAS DISCHARGED FROM HOSPITAL. HE WAS ALREADY UNDER ANTICOAGULANT PREVENTIVE TREATMENT."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED PHLEBITIS WHEN THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WITH WINGS WAS USED ON THEM. AS A RESULT, THEY REMAINED HOSPITALIZED FOR A LONGER PERIOD WHILE UNDER ANTICOAGULANT PREVENTIVE TREATMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "PUNCTURE SITE INFLAMED AND SWOLLEN ON THE PATH OF THE VEIN. CLINICAL CONSEQUENCES: PHLEBITIS, INFECTION". "THIS DECLARATION WAS MADE BECAUSE THIS COMPLICATION HAS BEEN FREQUENT FOR SEVERAL MONTHS." "THE PATIENT WAS DISCHARGED FROM HOSPITAL. HE WAS ALREADY UNDER ANTICOAGULANT PREVENTIVE TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139582 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WITH WINGS INTRAVASCULAR CATHETER FOZ 0223143

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention