BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INSYTE AUTOGUARD BC 20GA CATHETER

    MDR report key: 10078724 · Received May 21, 2020

    Report

    Report Number
    1710034-2020-00321
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    March 30, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825340
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY FIVE PHOTOS APPEARING TO DISPLAY THE SAME LOOSE 1ML SYRINGE WITH AN OPENED BLISTER PACK FROM BATCH 8211605 WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THE THUMB REST WAS BROKEN OFF WITH ONLY HALF OF THE BROKEN PIECE VISIBLE IN THE PHOTOS, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE BROKEN PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8211605 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER SPLIT WHILE INSERTING WITH AN UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ BC 20 GA CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT PLASTIC CATHETER AROUND THE NEEDLE SPLIT AT THE TOP WHEN INSERTING IV INTO VEIN. ADDITIONALLY, ON 2020-05-04 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: HOW MANY TIMES HAS THE INCIDENT OCCURRED? WHEN WE FIRST STARTED USING THIS PRODUCT WE HAVE THIS HAPPEN QUITE OFTEN THESE ARE THE FIRST TWO THAT HAVE BEEN REPORTED. ARE THERE MORE TIMES THIS HAS OCCURRED, THAT COULD BE POSSIBLE AND THE PERSON STARTING THE IV DOESN¿T REPORT THIS. ARE YOU ABLE TO PROVIDE DATES AND/OR PATIENT IDENTIFIERS? FOR THE 20 GA X 1.16 PRODUCT # 382534 IT WAS ON (B)(6) 2020 ¿ THE 22GA X 1 IN PRODUCT # 382523, I HAVE NO LOT # FOR THIS ONE, THEY DIDN¿T SAVE THE PACKAGE. NO PATIENT HARM WITH EITHER OF THESE. WERE THERE ERRONEOUS RESULTS? N/A. WAS THERE EXPOSURE TO BLOOD/BODILY FLUID? N/A. ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES I HAVE BOTH OF THESE CATHETERS THAT I CAN SEND BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541600 UNSPECIFIED BD INSYTE AUTOGUARD BC 20GA CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382534 9325436 30382903825340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other