BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI PCA EXT SET 67IN NDEHP W/INJECTOR

    MDR report key: 3801685 · Received April 28, 2014

    Report

    Report Number
    9613251-2014-00095
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 31, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT NUMBER IS 0039-0111-2014-008. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH WAS RECEIVED THAT STATED THE FOLLOWING: "THE PATIENT HAD A SMALL BORE CENTRAL CATHETER TO WHICH THE PCA TUBING WAS ATTACHED. NURSE ATTEMPTED TO DISCONNECT THE PCA TUBING FROM THE CENTRAL LINE AND THE END OF THE PCA TUBING BROKE OFF INSIDE THE LUMEN OF THE CENTRAL LINE." UPON FURTHER QUERY, THE FOLLOWING INFORMATION WAS PROVIDED THAT INDICATED BREAKAGE OF THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER. THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE PATIENT'S PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) AND WAS BEING USED TO DELIVER DILAUDID 1MG/ML, AT AN UNSPECIFIED RATE, VIA AN UNSPECIFIED PATIENT-CONTROLLED ANALGESIA (PCA) PUMP. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT WHEN THE NURSE WAS DISCONNECTING THE OPTION-LOK MALE ADAPTER FROM THE PATIENT'S PICC LINE, THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER BROKE OFF AND A PIECE REMAINED LODGED INSIDE THE LUMEN OF THE PICC LINE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE IN THE INTERVENTIONAL RADIOLOGY DEPARTMENT FOR THE REPLACEMENT OF THE PICC LINE. AT AN UNSPECIFIED TIME, THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THE CUSTOMER CONTACT REPORTED THERE WAS NO CHANGE IN THE PATIENT'S CONDITION AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253284 MINI PCA EXT SET 67IN NDEHP W/INJECTOR 80MEA MEA HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention UNSPECIFIED CENTRAL LINE CATHETER, MFR UNK