BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 10301878 · Received July 21, 2020

    Report

    Report Number
    1710034-2020-00466
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    June 30, 2020
    Report Date
    August 18, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815440
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED AN 18 GAUGE INSYTE AUTOGUARD WINGED CATHETER ADAPTER ASSEMBLY FROM LOT 0023722 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED DAMAGE TO THE TIP OF THE CATHETER TUBING. A MICROSCOPIC INSPECTION WAS THEN PERFORMED ON THE CATHETER TIP AND A SMALL PART OF THE CATHETER MATERIAL IS MISSING FROM THE CATHETER TUBING RESULTING IN A JAGGED TIP. TEARING TO THE CATHETER TUBING CAN ALSO BE OBSERVED ON THE SIDES OF A DISTINCTIVE V SHAPE POINT. THIS V SHAPE INDICATED THAT THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING. THE TEARING TO THE CATHETER AND THE SPEAR THROUGH RESULTED IN THE CATHETER FOLDING INTO ITSELF SEEN ABOVE. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BUT IT DIDN'T APPEAR TO BE A MANUFACTURING DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER BROKE FROM THE HUB DURING USE AND WAS "BENT/SMASHED." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER CALLED TO REPORT THAT A COUPLE OF NURSES HAVE BROUGHT CATHETERS TO HER STATING THAT THEY DON'T ADVANCE AND THE CATHETERS ARE EITHER BORKEN AT THE TIP OR BENT/SMASHED. SHE WAS UNABLE TO PROVIDE DATES OR PATIENT IDENTIFIERS, SHE STATED IT HAS HANPPENED A HANDFUL OFF TIMES."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER BROKE FROM THE HUB DURING USE AND WAS "BENT/SMASHED". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER CALLED TO REPORT THAT A COUPLE OF NURSES HAVE BROUGHT CATHETERS TO HER STATING THAT THEY DON'T ADVANCE AND THE CATHETERS ARE EITHER BROKEN AT THE TIP OR BENT/SMASHED. SHE WAS UNABLE TO PROVIDE DATES OR PATIENT IDENTIFIERS, SHE STATED IT HAS HAPPENED A HANDFUL OFF TIMES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770356 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381544 0023722 30382903815440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other