BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICP LUER ADAPTOR

    MDR report key: 5700550 · Received June 6, 2016

    Report

    Report Number
    1226348-2016-10405
    Event Type
    Injury
    Date Received
    June 6, 2016
    Date of Event
    May 20, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HCD
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED; THEREFORE, WE WERE NOT ABLE TO REVIEW THE MANUFACTURING RECORDS OF THIS DEVICE OR DETERMINE WHETHER THERE HAVE BEEN SIMILAR COMPLAINTS AGAINST THIS LOT. EVALUATION OF THE RETURNED DEVICE FOUND THAT IT HAD APPEARED TO SEPARATE ALONG THE MOLD PARTING LINES. THE DEVICE FAILED A LEAK TEST. WHILE THE REPORTED ISSUE WAS CONFIRMED, WE WERE UNABLE TO DETERMINE THE DIRECT CAUSE OF FAILURE BASED ON THE DEVICE AS IT WAS RETURNED. WHILE NO LOT NUMBER WAS PROVIDED, A REVIEW OF ALL COMPLAINTS AGAINST THIS PART NUMBER OVER THE LAST 12 MONTHS DID NOT REVEAL ANY SIMILAR COMPLAINTS. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REP INFORMED ME OF A LEAKAGE PROBLEM OCCURRING AT THE CONNECTOR BETWEEN THE BACTISEAL EVD CATHETER 82-1745 AND THE CODMAN REFERENCE 821731 EXTERNAL DRAINAGE SYSTEM EDS3. THE CONNECTOR = CODMAN ITEM 16-1057. EVEN THOUGH THE 821731 WAS CONNECTED CAREFULLY TO THE 161057, A CRACK IN THE FEMALE LUER LOCK CONNECTOR PART WAS OBSERVED. ANOTHER 161057 HAD TO BE CONNECTED TO MAKE THE CONNECTION BETWEEN THE 821745 CATHETER AND THE 821731 DRAINAGE SYSTEM. A SIMILAR PROBLEM WAS ALREADY COMMUNICATED IN THE PAST (COMPLAINT DD 14 AUG 2014; (B)(4)). ON 5/24/2016 PER AFFILIATE: THE PROBLEM WAS NOT SEEN AS "INTRA-OPERATIVELY" AS THE PATIENT WAS ALREADY ON THE INTENSIVE CARE DEPARTMENT. THE SURGEON MENTIONED THE LEAKING BECAUSE AIR HAD COME INTO THE DRAIN BY WHICH A FLUID COUPLED TRANSDUCER WAS CONNECTED (BY A THREE-WAY VALVE OF THE ASSOCIATED COLLECTING SYSTEM 821731). THEREFORE THE INTRACRANIAL PRESSURE ALSO WASN'T WELL MEASURED. THE PATIENT DIDN'T SEEM TO HAVE CAUGHT UP SOME CONSEQUENCES, BUT THE SURGEON IS IN THESE CASES ALWAYS APPREHENSIVE FOR INFECTIONS (CAVE MENINGITIS). THE DEFECTIVE WHITE CONNECTOR WAS REMOVED AND REPLACED BY A CONNECTOR WHICH WAS ENCLOSED TO THE BACTISEAL EVD CATHETER (REFERENCE 821749). THIS IS A LARGE LUMEN CATHETER. THE CONNECTOR IS SIMILAR TO THE 161057 BUT IS TRANSPARENT INSTEAD OF WHITE AND HAVE SOME SMALL DIFFERENCES IN HIS CONFIGURATION. THIS TRANSPARENT CONNECTOR ISN'T AVAILABLE SEPARATELY. THE REPLACEMENT OF THE CONNECTOR DIDN'T TOOK THAT LONG, HOWEVER IT TOOK SOME TIME TO FIND THIS REPLACING ELEMENT (1.5H). MAY WE ALSO KINDLY INDICATE THAT THIS SURGEON ALSO ALREADY RAISED THIS COMPLAINT BEFORE ((B)(4)) AND SHE DOESN'T HAVE THE FEELING THAT A LOT HAS BEEN DONE IN ORDER TO AVOID THIS PROBLEM IN THE FUTURE. THIS IS SOMETHING SHE REGRETS. SHE ALSO REGRETS IT THAT THE TRANSPARENT CONNECTOR WHICH BELONGS TO THE 821749 CATHETER ISN'T AVAILABLE ON ITS OWN. FURTHERMORE THERE HAS ALSO BEEN ANOTHER SAME LIKE COMPLAINT FROM THIS HOSPITAL WHICH WAS RAISED BY THE PHARMACIST. THIS WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355611 ICP LUER ADAPTOR INTRACRANIAL CANNULA HCD CODMAN & SHURTLEFF, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention