BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8181619 · Received December 19, 2018

    Report

    Report Number
    1710034-2018-00902
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 25, 2018
    Report Date
    February 13, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH POOR ADHERENCE OF PRIMARY PACKAGING LOSING STERILITY. THIS WAS REPORTED TO HAVE AFFECTED 300 PACKAGES. H.6. INVESTIGATION SUMMARY: DHR REVIEWS: REVIEW OF DHRS REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THESE LOTS THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. INDETERMINATE ¿ WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH POOR ADHERENCE OF PRIMARY PACKAGING LOSING STERILITY. THIS WAS REPORTED TO HAVE AFFECTED 300 PACKAGES.

    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 #: 7122842. MEDICAL DEVICE EXPIRATION DATE: 2020-04-30. DEVICE MANUFACTURE DATE: 2017-05-03. MEDICAL DEVICE LOT #: 7342715. MEDICAL DEVICE EXPIRATION DATE: 2020-11-30. DEVICE MANUFACTURE DATE: 2017-12-14. MEDICAL DEVICE LOT #: 8036971. MEDICAL DEVICE EXPIRATION DATE: 2021-01-31. DEVICE MANUFACTURE DATE: 2018-02-05. MEDICAL DEVICE LOT #: 7250624. MEDICAL DEVICE EXPIRATION DATE: 2020-08-31. DEVICE MANUFACTURE DATE: 2017-09-07. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH POOR ADHERENCE OF PRIMARY PACKAGING LOSING STERILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017607 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other