BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESTEP HUBER NEEDLE SET 20G X 1 IN WITH Y-SITE

    MDR report key: 8597218 · Received May 9, 2019

    Report

    Report Number
    3006260740-2019-01322
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Report Date
    May 9, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FPA
    UDI-DI
    00801741066238
    PMA / PMN Number
    K153440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE ANALYSIS, APPLICABLE FMEA DOCUMENTS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAK IN THE SAFESTEP INFUSION SET WAS INCONCLUSIVE DUE TO THE SAMPLE CONDITION. TWO PHOTOGRAPHS WERE THE ONLY ITEMS RETURNED FOR INVESTIGATION. ONE PHOTO SHOWED THE PRODUCT LABEL WITH P/N LH-0032YN AND LOT ASCRS0086. THE OTHER PHOTO SHOWED A 20G SAFESTEP INFUSION SET WITH Y-SITE. THE CLAMP WAS CLOSED OVER THE EXTENSION SET TUBING BETWEEN THE LUER ADAPTOR AND THE Y-SITE. THE PROTECTIVE NEEDLE COVER WAS STILL ATTACHED TO THE NEEDLE. THE DEAD END CAP WAS STILL ATTACHED TO THE LUER ADAPTOR. THE ALLEGED LEAK OR BREACH IN THE DEVICE COULD NOT BE DISCERNED FROM THE PHOTOGRAPH. WITHOUT THE PHYSICAL SAMPLE OR IRREFUTABLE PHOTOGRAPHS, THE COMPLAINT COULD NOT BE CONFIRMED. A LOT HISTORY REVIEW (LHR) OF ASCRS0086 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FROM THE LUER LOCK SYSTEM TO THEY LEAKED AT THE TIP END. THEY HAVE REPORTEDLY BEEN PLACING AN END CP ON TO PREVENT THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387548 SAFESTEP HUBER NEEDLE SET 20G X 1 IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS N/A ASCRS0086 00801741066238

    Patients

    Seq Age Sex Outcome Treatment
    1