BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTION SHIELD

    MDR report key: 2944946 · Received February 6, 2013

    Report

    Report Number
    1416980-2013-03015
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE SAMPLE WAS RECEIVED AND EVALUATED. THE SAMPLE WAS MARKED BY THE PATIENT IN ORDER TO INDICATE WHERE THE PATIENT PERCEIVED HOLES IN THE PACKAGING. THE SAMPLE WAS HELD UP TO A LIGHT SOURCE, AND NO LIGHT PENETRATION WAS NOTED. THERE WAS NO IODINE STAINING ON THE OUTSIDE OF THE POUCHES. AN EVALUATION WAS PERFORMED IN THE (B)(4) WHEREBY IODINE WAS PLACED DIRECTLY ON THE INNER SURFACE OF THE POUCH AT THE LOCATION WHERE IT HAD BEEN INDICATED THERE WAS A HOLE. THE IODINE DID NOT PENETRATE TO THE OUTER SURFACE OF THE POUCH. THE SAMPLES WERE VISUALLY INSPECTED AND NO LIGHT PENETRATION OR HOLE WAS NOTED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THIS COMPLAINT FOR A REPORT OF A PACKAGING RELATED DEFECT WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(4) 2013, A NURSE REPORTED THAT A PATIENT HAD REPORTED THAT WHEN HE HELD HIS CLAMSHELL UP TO A LIGHT, HE COULD SEE "SMALL LIGHT HOLES" IN THE PACKAGING. THE PATIENT REPORTED THAT THE SPONGES WERE NOT DRIED OUT. THE OCCURRENCE DATE WAS NOT REPORTED. THE SAMPLE WAS AVAILABLE AND REQUESTED FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. THIS COMPLAINT ADDRESSES A SAMPLE WHICH BAXTER BECAME AWARE OF ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50509 CONNECTION SHIELD DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 12I20H12

    Patients

    Seq Age Sex Outcome Treatment
    1