BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 4182556 · Received October 17, 2014

    Report

    Report Number
    1722028-2014-00416
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 24, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK120049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DONOR/PATIENT ACCESS CONNECTION (INLET LUER CONNECTION) FROM THE DISPOSABLE SET WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION VERIFIED THAT THE END OF THE MALE LUER WAS LODGED IN THE FEMALE LUER, PRESUMABLY BECAUSE THE USER HAD TO USE EXCESSIVE FORCE TO ATTEMPT TO DISCONNECT THE CONNECTORS. THE FEMALE LUER CONNECTOR WAS ONLY INCLUDED, ON INSPECTION NO OBVIOUS DEFECTS SUCH AS EXCESS SOLVENT OR FLASH WERE FOUND. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT AND NONE HAVE BEEN REPORTED. ROOT CAUSE: THE FAILURE OF LUER CONNECTORS TO UNSCREW MAY BE RELATED TO:- MANUFACTURING, WHEREBY THE ASSEMBLER HAS HAND-TIGHTENED THE LUER EXCESSIVELY AND/OR- SMALL VARIATIONS IN THE PART DIMENSIONS.

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED APPROPRIATELY OF THE MDR FORM. THIS SUPPLEMENT IS BEING FILED TO MODIFY INFORMATION TO ALIGN WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT THE END OF PRIME FOR A STEM CELL COLLECTION PROCEDURE, THEY WERE UNABLE TO DISCONNECT THE FISTULA NEEDLE FROM THE ACCESS LINE, PRIOR TO THE CONNECTION TO THE PATIENT'S DIALYSIS LINE. PER THE CUSTOMER, A SECTION OF THE LUER LOCK REMAINED BONDED TO THE NEEDLE. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Description of Event or Problem · 1

    PER THE CUSTOMER, THIS INCIDENT DID NOT RESULT IN HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660082 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT 03W3105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other