BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD BC

    MDR report key: 8833526 · Received July 26, 2019

    Report

    Report Number
    1710034-2019-00797
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 8, 2019
    Report Date
    October 11, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES PROVIDED. BD RECEIVED 21 INSYTE AUTOGUARD BC 22GA UNITS FROM LOT NUMBER: 9071791 WITHIN SEALED PACKAGES ALONG WITH 2 EMPTY-OPEN PACKAGES AND A PIECE OF TOP WEB PAPER. SIX UNITS WERE RECEIVED FROM LOT NUMBER: 9099672 THAT WERE WITHIN SEALED PACKAGES ALONG WITH ONE EMPTY-OPEN PACKAGE. THROUGH THE VISUAL/MICROSCOPIC EVALUATION, THERE WAS NO PHYSICAL-MECHANICAL DAMAGE OBSERVED ON ANY OF THE COMPONENTS OF THE RECEIVED UNITS. A WATER LEAK TEST WAS PERFORMED WHERE LEAKAGE WAS NOT OBSERVED WITH ANY OF THE UNITS. THE RETURNED REPRESENTATIVE UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT EXPERIENCED. THE FAILURE DESCRIBED COULD NOT BE REPLICATED AT THE LABORATORY. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FIVE 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD BC EXPERIENCED A HOLE IN THE CATHETER WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USER FACILITY SENT A CONCERN FOR 22GA X1 INCH CATH IV INSYTE THEY HAVE FOUND 5 WITH HOLES IN THE CATHETER. 2 DIFFERENT LOTS. PER PHONE: PRODUCT#: 382523, LOTS: 9071791 AND 9099672. HOLES WERE SEEN IN CATHETER BEFORE USE, RIGHT WHEN OPENED PACKAGE. NO PATIENT USE. DATES OF OCCURRENCE WERE NOT TOLD.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 #: 9071791, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: 2019-03-12. MEDICAL DEVICE LOT #: 9099672, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2019-04-09.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIVE 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD BC EXPERIENCED A HOLE IN THE CATHETER WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USER FACILITY SENT A CONCERN FOR 22GA X1 INCH CATH IV INSYTE THEY HAVE FOUND 5 WITH HOLES IN THE CATHETER. 2 DIFFERENT LOTS. PER PHONE: PRODUCT # 382523, LOTS 9071791 AND 9099672. HOLES WERE SEEN IN CATHETER BEFORE USE, RIGHT WHEN OPENED PACKAGE. NO PATIENT USE. DATES OF OCCURRENCE WERE NOT TOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623954 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other