BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECNDRY SET 34IN NDEHP WITH EXT HOOK

    MDR report key: 3894361 · Received April 23, 2014

    Report

    Report Number
    9613251-2014-00094
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 28, 2014
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED SECONDARY TUBING SET AND ONE USED PRIMARY TUBING SET WERE RECEIVED AND EVALUATED. TESTING FOUND THAT THE OPTION-LOK MALE ADAPTER OF THE SECONDARY TUBING SET WAS BROKEN OFF IN PROXIMAL CLAVE Y-SITE OF THE PRIMARY TUBING SET. WHITE DRAG MARKS WERE NOTED ON THE OPTION-LOK MALE ADAPTER INDICATING APPLICATION OF FORCE ON THE MALE ADAPTER. HOSPIRA HAD COMPLETED A FORMAL INVESTIGATION TO ADDRESS SIMILAR COMPLAINTS DUE TO SPIN COLLAR OPTION-LOK CONNECTION PROBLEMS WITH OTHER DEVICES WHICH RESULTED IN LEAKS, CRACKS AND GENERAL CONNECTIONS EVENTS. BASED UPON THE INVESTIGATION RESULTS, HOSPIRA HAS IDENTIFIED THAT IT NEEDS TO MAKE DIMENSIONAL CHANGES TO THE SPIN COLLAR THAT WILL IMPROVE THE COMPLIANCE WITH THE ISO STANDARD (594-2) AND INTERACTION WITH OTHER COMPONENTS. THE PLANNED IMPROVEMENTS WILL OPTIMIZE THE DESIGN OF THE THREAD, TAPER AND TAPER PROTRUSION OF THE OPTION-LOK TO MINIMIZE IDENTIFIED FAILURE MODES AND RESULTANT COMPLAINTS. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BREAKAGE OF THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER. THE CUSTOMER CONTACT REPORTED THAT A PRIMARY TUBING SET WAS BEING USED TO DELIVER NORMAL SALINE VIA GRAVITY. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF THE SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL CLAVE Y-SITE OF THE PRIMARY TUBING SET FOR A PIGGYBACK DELIVERY OF DEXAMETHASONE 10 MG. THE CUSTOMER CONTACT REPORTED THAT AFTER THE PIGGYBACK DELIVERY WAS COMPLETE, THE NURSE DISCONNECTED THE SECONDARY TUBING SET FROM THE CLAVE Y-SITE. AT THAT TIME, IT WAS REPORTED THAT THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER BROKE OFF IN THE CLAVE Y-SITE AND AN UNSPECIFIED VOLUME OF NORMAL SALINE LEAKED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THE PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245873 SECNDRY SET 34IN NDEHP WITH EXT HOOK 80FPA FPA HOSPIRA, LTD NA 360644W

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR PRIMARY TUBING SET, LIST #12662, LOT #UNK