BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 17666259 · Received August 31, 2023

    Report

    Report Number
    1710034-2023-00996
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 11, 2023
    Report Date
    September 29, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825128
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D.4 DEVICE EXPIRATION DATE: UNKNOWN. H.4 DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED TWO PHOTOGRAPHS. THE FIRST PHOTOGRAPH DISPLAYED THE SHIPPER CASE (200 UNITS) WITH A LABEL WITH YELLOW STRIPES FOR LOT #3093660 AND PART NUMBER 382512-BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER 24 GA X 0.75 IN. THE SECOND PHOTOGRAPH SHOWED A DISPENSER BOX (50 UNITS) WITH A LABEL WITH YELLOW STRIPES FOR LOT #3093652 AND PART NUMBER 381812-BD INSYTE AUTOGUARD 20 GA X 0.75IN. PART NUMBER 381812 DOES NOT HAVE BLOOD CONTROL TECHNOLOGY AND SHOULD NOT CONTAIN THE YELLOW STRIPES ON THE LABEL. THERE WER NO UNIT LABELS SHOWN IN EITHER PHOTOGRAPH. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO AN OPERATOR ERROR DURING THE PACKAGING PROCESS. THE WRONG BATCH IDENTIFICATION MAY OCCUR BECAUSE OF A MACHINE SETUP CHANGE OVER, WRONG LABEL, OR INCOMPLETE LINE CLEARANCE. MACHINE SETUP AND OPERATOR TRAINING ARE PERFORMED TO MITIGATE THE OCCURRENCE OF THIS DEFECT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 23 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER LABEL INFORMATION WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CALLED IN TO REPORT THAT CUSTOMER ORDERED PART NUMBER 382512, HOWEVER LABEL SHOWED SOMETHING DIFFERENT. HAS ONE CASE AND 23 EACHES WITH THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 23 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER LABEL INFORMATION WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CALLED IN TO REPORT THAT CUSTOMER ORDERED PART NUMBER 382512, HOWEVER LABEL SHOWED SOMETHING DIFFERENT. HAS ONE CASE AND 23 EACHES WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603873 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3093660 30382903825128

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown