BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD PNK 20GA X 1.16IN

    MDR report key: 8625466 · Received May 20, 2019

    Report

    Report Number
    1710034-2019-00534
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 26, 2019
    Report Date
    July 11, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814344
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE PROVIDED. BD RECEIVED ONE INSYTE AUTOGUARD 20GA CATHETER-ADAPTER ASSEMBLY ATTACHED TO A MISCELLANEOUS NEEDLELESS CONNECTOR. THROUGH THE VISUAL/MICROSCOPIC EVALUATION THERE WAS NO PHYSICAL-MECHANICAL DAMAGE OBSERVED ON ANY OF THE COMPONENTS OF THE UNIT RECEIVED. A WATER-LEAK TEST WAS PERFORMED WHERE THE ADAPTER WAS CONNECTED TO A SLIP LUER FITTING. LEAKAGE WAS NOT OBSERVED. THE SLIP LUER FITTING WAS THEN CONNECTED TO THE END OF THE MISCELLANEOUS NEEDLELESS CONNECTOR WITH THE ADAPTER ATTACHED TO IT. LEAKAGE WAS NOT OBSERVED. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN THE REPORT. 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 LEAKAGE OCCURRED WITH A INSYTE AUTOGUARD PNK 20GA X 1.16IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN THE HUB WAS FLUSHED WITH A SALINE FLUSH THERE WAS A VISIBLE LEAK WITHIN THE WALLS OF THE HUB. "WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE, RESPOND ACCORDINGLY WITH THE RMA NUMBER, IF NECESSARY, AND THE DISPOSITION OF THE CUSTOMER'S CONCERN. INJURIES OR ADVERSE EVENT: NO QUANTITY AFFECTED: 1 CS SERIAL/LOT NUMBER: POSSIBLY ¿ (B)(6) ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: PER CUSTOMER - WHEN HUB WAS FLUSHED WITH A SALINE FLUSH THERE WAS A VISIBLE LEAK WITHIN THE WALLS OF THE HUB. RESULTING IN THE IN ABILITY TO ADMINISTER MEDICATION PROPERLY. THEREFORE; THE INSYTE CATH WAS REMOVED AND REPLACED WITH A NEW INSYTE. LOT# UNKNOWN BUT WOULD BE AMONG A RANGE OF LOT#8331792, 8173542, 9002921 AND 9021528. THE PACKAGING WITH THE LOT NUMBER HAD BEEN THROWN AWAY AND THEY PULLED WHAT THEY HAD TO HOPEFULLY NARROW DOWN A POSSIBLE AFFECTED LOT. "

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO POSSIBLY BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8173542, MEDICAL DEVICE EXPIRATION DATE: 2021-05-31, DEVICE MANUFACTURE DATE: 2018-06-22. MEDICAL DEVICE LOT #: 8331792, MEDICAL DEVICE EXPIRATION DATE: 2021-11-30, DEVICE MANUFACTURE DATE: 2018-11-27. MEDICAL DEVICE LOT #: 9002921, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2019-01-02. MEDICAL DEVICE LOT #: 9021528, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2019-01-21. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A INSYTE AUTOGUARD PNK 20GA X 1.16IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN THE HUB WAS FLUSHED WITH A SALINE FLUSH THERE WAS A VISIBLE LEAK WITHIN THE WALLS OF THE HUB. "WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE, RESPOND ACCORDINGLY WITH THE RMA NUMBER, IF NECESSARY, AND THE DISPOSITION OF THE CUSTOMER'S CONCERN. INJURIES OR ADVERSE EVENT: NO. QUANTITY AFFECTED: 1 CS. SERIAL/LOT NUMBER: POSSIBLY ¿ 8173542, 8331792, 9002921 OR 9021528. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: PER CUSTOMER - WHEN HUB WAS FLUSHED WITH A SALINE FLUSH THERE WAS A VISIBLE LEAK WITHIN THE WALLS OF THE HUB. RESULTING IN THE IN ABILITY TO ADMINISTER MEDICATION PROPERLY. THEREFORE; THE INSYTE CATH WAS REMOVED AND REPLACED WITH A NEW INSYTE. LOT# UNKNOWN BUT WOULD BE AMONG A RANGE OF LOT#8331792, 8173542, 9002921 AND 9021528. THE PACKAGING WITH THE LOT NUMBER HAD BEEN THROWN AWAY AND THEY PULLED WHAT THEY HAD TO HOPEFULLY NARROW DOWN A POSSIBLE AFFECTED LOT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416209 INSYTE AUTOGUARD PNK 20GA X 1.16IN INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 30382903814344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other