BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 10099289 · Received May 28, 2020

    Report

    Report Number
    1710034-2020-00338
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    April 7, 2020
    Report Date
    June 30, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815341
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD RECEIVED 470 INSYTE AUTOGUARD 20 GAUGE UNITS FROM LOTS 9331463 AND 9325479 FOR INVESTIGATION. FOUR HUNDRED UNITS WERE FROM LOT 9331463 AND SEVENTY UNITS WERE FROM 932579. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR BOTH LOTS AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED 152 UNITS RANDOMLY SELECTED FROM LOT 9331463 AND ALL 70 UNITS FROM LOT 9325479. NO DEFECTS WERE OBSERVED WITH ANY OF THE UNITS. THE CATHETERS DID NOT BECOME SEPARATED FROM THE DEVICES DURING TESTING. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE OBSERVED DURING INSPECTION THE ENGINEER COULD NOT IDENTIFY A DEFINITIVE ROOT CAUSE FOR THIS REPORTED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER COULDN'T BE COMPLETELY PULLED FROM THE VEIN DURING USE, AND IT SEPARATED FROM THE HUB AS A RESULT. LOT# 9331463 WAS REPORTED TO HAVE HAD 8 OCCURRENCES OF THIS EVENT, WHILE LOT# 9325479 WAS REPORTED TO HAVE HAD 69 OCCURRENCES OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CATHETER WAS NOT ALL THE WAY INSERTED WHEN IT WAS NOTICED THAT IS WAS UNATTACHED AND ABLE TO BE PULLED FROM THE VEIN COMPLETELY. THE CATHETER BECAME DISLODGED FROM THE PINK-WINGED ATTACHMENT."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9331463. MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. DEVICE MANUFACTURE DATE: 2019-11-27. MEDICAL DEVICE LOT #: 9325479. MEDICAL DEVICE EXPIRATION DATE: 2022-10-31. DEVICE MANUFACTURE DATE: 2019-11-22. 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 THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER COULDN'T BE COMPLETELY PULLED FROM THE VEIN DURING USE, AND IT SEPARATED FROM THE HUB AS A RESULT. LOT# 9331463 WAS REPORTED TO HAVE HAD 8 OCCURRENCES OF THIS EVENT, WHILE LOT# 9325479 WAS REPORTED TO HAVE HAD 69 OCCURRENCES OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CATHETER WAS NOT ALL THE WAY INSERTED WHEN IT WAS NOTICED THAT IS WAS UNATTACHED AND ABLE TO BE PULLED FROM THE VEIN COMPLETELY. THE CATHETER BECAME DISLODGED FROM THE PINK-WINGED ATTACHMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558634 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381534 SEE SECTION H.10. 30382903815341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other