BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 10614408 · Received October 1, 2020

    Report

    Report Number
    1710034-2020-00632
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 9, 2020
    Report Date
    November 2, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED THREE UNUSED INSYTE AUTOGUARD BC 22GA UNITS IN SEALED PACKAGES FROM MATERIAL NUMBER 382523, LOT NUMBER 0016699. IN ADDITION, ONE PHOTOGRAPH WAS ALSO SUBMITTED. THE PHOTO DID NOT PROVIDE SUFFICIENT EVIDENCE TO CONFIRM A DEFECT. UPON INSPECTION OF THE RETURNED UNITS IT WAS FOUND THAT TWO UNITS HAD POOR PERFORATION. THE REPORTED ISSUE WAS CONFIRMED. THE DEFECT IS AN INCOMPLETE CUT, WHICH CAN RESULT FROM DULL/DAMAGE PERF KNIFE, NORMAL WEAR, MISORIENTED UNIT STICKING OUT OF THE PACKAGE, LOW CUTTING PRESSURE, OR MACHINE JAMS. THIS PATTERN IS INDICATIVE OF THE LOW PRESSURE ON THE CUTTING KNIFE. LOW PRESSURE IS A RESULT OF A GUARD DOOR BEING OPEN, FROM EITHER A MACHINE JAM OR A PACKAGED TRIM JAM IN THE CHAIN. THIS WAS THE PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO THE PACKAGING PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD A SEPARATING ISSUE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382523 BATCH NO: 0122389 IT WAS REPORTED THAT THE PRODUCT IS RIPPING WHEN TRYING TO SEPARATE. QUESTIONS/INQUIRIES (B)(6) 2020 SPOKE WITH CUSTOMER, SHE STATED THAT THE LINES TO SEPARATE TO PRODUCTS IS SOLID INSTEAD OF IT BEING PERFORATED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD A SEPARATING ISSUE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382523, BATCH NO: 0122389. IT WAS REPORTED THAT THE PRODUCT IS RIPPING WHEN TRYING TO SEPARATE. QUESTIONS/INQUIRIES: (B)(6) 2020 SPOKE WITH CUSTOMER, SHE STATED THAT THE LINES TO SEPARATE TO PRODUCTS IS SOLID INSTEAD OF IT BEING PERFORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076469 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 0122389 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other