BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G X 1" W/Y-SITE WINGED INFUSION SET

    MDR report key: 9560611 · Received January 7, 2020

    Report

    Report Number
    3006260740-2020-00018
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 10, 2019
    Report Date
    February 12, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, COMPLAINT AND LOT HISTORY, APPLICABLE PREVIOUS INVESTIGATION(S), LABELING, APPLICABLE MANUFACTURING RECORDS, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAKING CONNECTION WAS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. ONE 20 GA W/YSITE WINGED INFUSION SET WAS RETURNED FOR INVESTIGATION. AN EXTENSION SET WAS ATTACHED TO THE Y-SITE CONNECTOR. THE SAMPLE WAS FLUSHED WITH WATER USING A 12 ML SYRINGE AND A LEAK WAS OBSERVED AT THE Y SITE HUB. A MICROSCOPIC OBSERVATION OF THE LEAK LOCATION REVEALED A LONGITUDINAL CRACK FROM THE TOP OF THE CONNECTOR DOWN TO THE Y SITE STEM. SUPERFICIAL FISSURES WHERE ALSO PRESENT IN THE CONNECTOR MATERIAL. THE FRACTURE CHARACTERISTICS INDICATE THAT OUTWARD RADIATING FORCES LIKELY CONTRIBUTED TO THE REPORTED ISSUE. POSSIBLE CONTRIBUTING FACTORS INCLUDE OVER-TIGHTENING EXTERNAL LUER CONNECTIONS. SINCE A LEAK IN THE HUB WAS OBSERVED TO BE THE CAUSE OF THE LEAK, THE COMPLAINT IS CONFIRMED. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN FLUSHING THE PORT SYSTEM, LEAKAGE WAS FOUND FROM THE CATHETER CONNECTOR. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN FLUSHING THE PORT SYSTEM, LEAKAGE WAS FOUND FROM THE CATHETER CONNECTOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22743 20G X 1" W/Y-SITE WINGED INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1