BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD

    MDR report key: 8509427 · Received April 12, 2019

    Report

    Report Number
    1710034-2019-00405
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 13, 2019
    Report Date
    July 5, 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

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE THREE PHOTOGRAPHS PROVIDED. PHOTO ONE DISPLAYED YELLOW PLASTIC BAGS WITH PACKAGES AND PRODUCT. PHOTO TWO DISPLAYED YELLOW PLASTIC BAGS INSIDE OF A LARGER CLEAR PLASTIC BAG. PHOTO THREE DISPLAYED YELLOW PLASTIC BAGS WITH PACKAGE AND PRODUCT. BASED ON THE EVALUATION OF THE SUBMITTED PHOTOS; THE PHOTOS DID NOT REVEAL ANY VISIBLE ANOMALIES OR DAMAGE THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. THE SOURCE COULD NOT BE CONFIRMED WITHOUT THE ACTUAL UNITS FOR OBSERVATION AND/OR EVALUATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 15 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD EXPERIENCED A BREACH IN STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: DEVICE THAT HAS ITS PACKAGING WITH ONE OF ITS ENDS UNCOVERED BY ISSUES INHERENT TO THE MANUFACTURER. QUANTITY AFFECTED FROM EACH BATCH: 7250624 - (B)(4) UNIT, 7342715 - (B)(4) UNIT, 8145844 - (B)(4) UNIT, 8071624 - (B)(4) UNIT, 7289646 - (B)(4) UNIT, 8016936 - (B)(4) UNIT AND 8036971 - (B)(4) UNIT.

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8071624, MEDICAL DEVICE EXPIRATION DATE: 2021-02-28, DEVICE MANUFACTURE DATE: 2018-03-12. MEDICAL DEVICE LOT #: 7289646, MEDICAL DEVICE EXPIRATION DATE: 2020-09-30, DEVICE MANUFACTURE DATE: 2017-10-30. MEDICAL DEVICE LOT #: 8016936, MEDICAL DEVICE EXPIRATION DATE: 2020-12-31, DEVICE MANUFACTURE DATE: 2018-01-16. 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. MEDICAL DEVICE LOT #: 7342715, MEDICAL DEVICE EXPIRATION DATE: 2020-11-30, DEVICE MANUFACTURE DATE: 2017-12-14. MEDICAL DEVICE LOT #: 8145844, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2018-05-25.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 15 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD EXPERIENCED A BREACH IN STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: DEVICE THAT HAS ITS PACKAGING WITH ONE OF ITS ENDS UNCOVERED BY ISSUES INHERENT TO THE MANUFACTURER. QUANTITY AFFECTED FROM EACH BATCH: 7250624 - 1 UNIT, 7342715 - 6 UNIT, 8145844 - 2 UNIT, 8071624 - 6 UNIT, 7289646 - 1 UNIT, 8016936 - 2 UNIT, 8036971 - 2 UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300469 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other