BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICP LUER ADAPTOR

    MDR report key: 4060885 · Received September 4, 2014

    Report

    Report Number
    1226348-2014-11942
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 11, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GCD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO ICP LUER ADAPTORS P/N 16-1057; LOT # 464837 WERE RETURNED TO CODMAN FOR EVALUATION. AS RECEIVED AND AFTER ETO DECONTAMINATION, IT WAS VERIFIED THAT BOTH ICP LUER ADAPTORS WERE CRACKED ON THE LUER ADAPTOR SIDE. ONE OF THE ADAPTORS HAS ONE CRACK AND THE SECOND ONE HAS TWO CRACKS. THE CAUSE(S) OF THE DAMAGES COULD NOT BE FULLY DETERMINED. IT APPEARS THAT BOTH ADAPTORS WERE OVER-TIGHTENED WITH THE COUNTERPART PRODUCT(S); HOWEVER, IT COULD NOT BE CONFIRMED. A LOT HISTORY RECORDS REVIEW FOR P/N 16-1057; LOT # 464837 WAS CONDUCTED, AND IT WAS VERIFIED THAT ALL PRODUCTS IN THIS LOT NUMBER WERE CONFORMING TO THE REQUIRED SPECIFICATIONS WHEN RELEASED TO STOCK ON JANUARY 16, 2014. A COMPLAINTS RECORDS REVIEW WAS ALSO CONDUCTED AND IT WAS VERIFIED THAT THIS IS THE FIRST COMPLAINT REPORTED FOR THIS PRODUCT DURING THE LAST FIVE YEARS AND IT IS CONSIDERED TO BE AN ISOLATED INCIDENT. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED 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

    THE AFFILIATE REPORTED "PLACEMENT OF A EXTERNAL VENTRICULAR DRAINAGE CATHETER 821745 AND CONNECTION TO A 821731 DRAINAGE COLLECTION SYSTEM BY MEANS OF A 16-1057 CONNECTOR 1079 PROCEDURE/SURGERY DATE (B)(6) 2014 (B)(4) -DESCRIBE EVENT ON (B)(6) 2014, DOCTOR 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. DUE TO BLOOD IN THE 821731, A NEW 821731 HAD TO BE COUPLED TO THE 821745 AND EVEN THOUGH THE 821731 WAS CONNECTED VERY CAREFULLY TO THE 161057, THE DOCTOR HEARD A KIND OF ?CLACK? NOISE AND SHE COULD SEE A CRACK IN THE FEMALE LUER LOCK CONNECTOR PART. TRYING WITH ANOTHER 161057 WITH THE SAME LOT NUMBER, JUST THE SAME PROBLEM HAPPENED AGAIN SO A THIRD CONNECTOR HAD TO BE CONNECTED AND THEN FINALLY THE CONNECTION WAS OK. WHEN I WAS PROVIDED WITH THE PRODUCTS, I COULD SEE A LITTLE CRACK AT THE FEMALE LUER LOCK PART OF BOTH RETURNED CONNECTORS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541599 ICP LUER ADAPTOR INTRACRANIAL CANNULA GCD CODMAN & SHURTLEFF, INC. 464837

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention