BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3161832 · Received June 3, 2013

    Report

    Report Number
    9615050-2013-01493
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 6, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS REC'D ON (B)(4) 2013 AND EVALUATED. TESTING FOUND THE TIP OF THE OPTION-LOK MALE ADAPTER WAS BROKEN OFF. WHITE DRAG MARKS WERE NOTED ON THE TIP OF THE OPTION-LOK MALE ADAPTER INDICATING AN APPLICATION OF LATERAL FORCE. 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 (B)(4) 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 INFO KNOWN BY THE RPTR 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. ON AN UNSPECIFIED DATE, THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO A FEMALE ADAPTER OF A BROVIAC CATHETER AND WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF TOTAL PARENTERAL NUTRITION, VIA A PLUM PUMP. ON (B)(6) 2013 DURING THE EVENING SHIFT, IT WAS REPORTED THAT WHEN THE NURSE WAS DISCONNECTING THE DISTAL TIP OF THE OPTION-LOK MALE FROM THE FEMALE ADAPTER OF THE BROVIAC CATHETER, THE OPTION-LOK MALE ADAPTER BROKE OFF. IT WAS REPORTED THAT A PIECE OF THE OPTION-LOK MALE ADAPTER REMAINED LODGED INSIDE THE FEMALE ADAPTER. THE CUSTOMER CONTACT REPORTED THAT THE SURGEON WAS NOTIFIED. ON (B)(6) 2013 AT AN UNSPECIFIED TIME, THE SURGEON REMOVED THE BROVIAC CATHETER. IT WAS REPORTED THAT THE BROVIAC CATHETER HAD BEEN SCHEDULED TO BE REMOVED ON (B)(6) 2013, THEREFORE, THE BROVIAC CATHETER WAS NOT REPLACED. AT AN UNSPECIFIED TIME A PERIPHERAL IV WAS STARTED, THE TUBING SET WAS REPLACED, AND THE THERAPY WAS RESUMED. THE CUSTOMER CONTACT REPORTED THAT THE PT'S FEEDINGS WERE INCREASED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. ON (B)(6) 2013, THE PT WAS DISCHARGED TO HOME. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243606 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO UNSPECIFIED BROVIAC CATHETER, MFR UNK