BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAY SAFE/LUER LOCK ADAPTER 4 IN.

    MDR report key: 2191278 · Received July 19, 2011

    Report

    Report Number
    8030665-2011-00037
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 19, 2011
    Manufacturer
    REYNOSA MFG
    Product Code
    KDJ
    PMA / PMN Number
    K904806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS NURSE REPORTED THAT SHE HAD APPLIED A TRANSFER SET TO THE PT, AND THAT THE PT RETURNED TO THE CLINIC THREE DAYS LATER STATING THAT HE HAD NOTICED A LEAK DUE TO A HOLE IN THE TUBING. THE PT RECEIVED A PROPHYLACTIC DOSE OF ANTIBIOTICS AND A NEW EXTENSION SET WAS APPLIED. THE PT CONTINUES DIALYSIS WITHOUT FURTHER INCIDENT. THERE IS NO SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAY SAFE/LUER LOCK ADAPTER 4 IN. PERITONEAL EXTENSION SET KDJ REYNOSA MFG NA 11BR08110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA