BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER 22GA 1.00IN

    MDR report key: 11033248 · Received December 17, 2020

    Report

    Report Number
    1710034-2020-00809
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 20, 2020
    Report Date
    March 4, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-22. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED FOUR PACKAGE LABELS WITH THE PERFORATION SLIT PRESENT. IN ADDITION, FOUR UNUSED INSYTE AUTOGUARD 22GA DEVICES IN SEALED PACKAGING FROM MATERIAL NUMBER 381823, LOT NUMBER 0132284 WERE RECEIVED. THROUGH THE VISUAL/MICROSCOPIC EVALUATION, A PARTIAL SEPARATION BETWEEN ONE OF THE PAIRED PACKAGES WAS OBSERVED. THERE WAS AN AREA OF APPROXIMATELY 3 ½ INCHES WHERE THERE WAS NO PERFORATED SLIT PRESENT ON THE BOTTOM WEB. ON THE OTHER PAIR OF PACKAGES, NO PERFORATED SLIT ON THE BOTTOM WEB WAS OBSERVED. THE REPORTED ISSUE WAS CONFIRMED. THE PAIRED PACKAGES WERE ATTEMPTED TO BE PULLED APART IN WHICH THEY DID NOT EASILY SEPARATE FROM EACH OTHER. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO LOW PRESSURE ON THE BLADE DURING THE PACKAGING PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 4 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS 22GA 1.00IN THERE WAS POOR PERFORATION ON PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: PACKAGING CUTTING LINE IS NOT EASY TO TEAR.

    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 PRIOR TO USE WITH 4 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS 22GA 1.00IN THERE WAS POOR PERFORATION ON PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: PACKAGING CUTTING LINE IS NOT EASY TO TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497245 BD INSYTE AUTOGUARD SHIELDED IV CATHETER 22GA 1.00IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381823 0132284 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1