BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD CATHETER 5FR, 4 LUMEN, HEP

    MDR report key: 4711400 · Received April 20, 2015

    Report

    Report Number
    1060680-2015-00013
    Event Type
    Malfunction
    Date Received
    April 20, 2015
    Date of Event
    March 19, 2015
    Report Date
    April 14, 2015
    Manufacturer
    BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD.
    Product Code
    DQO
    PMA / PMN Number
    K911710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE QFI REPORT WAS REVIEWED FOR SALES AND SIMILAR COMPLAINT INFORMATION. DEROYAL HAS SOLD (B)(4) CASES OF THE FINISHED GOOD FROM 2013 TO 2015. THERE HAVE BEEN NO PREVIOUS REPORTS FOR THE IDENTIFIED DEFECT. THE FINISHED GOOD CONTAINS RAW MATERIAL (B)(4), WHICH IS SUPPLIED TO DEROYAL BY (B)(4). A VOICEMAIL WAS LEFT FOR THE VENDOR ON (B)(6) 2015. A RETURN CALL WAS RECEIVED AND THE REPORTED ISSUE WAS DISCUSSED WITH THE VENDOR CONTACT, (B)(4). DURING THE DISCUSSION, THE PICTURE OF THE COMPLAINT SAMPLE WAS PROVIDED. IT WAS IDENTIFIED THAT THE PROBABLE ROOT CAUSE FOR THE REPORTED ISSUE WAS END USE ERROR DUE TO OVERTIGHTENING OF THE DEVICE WITHIN THE SYRINGE. A SUPPLIER NOTIFICATION LETTER WAS ISSUED TO THE VENDOR FOR DOCUMENTATION OF AWARENESS OF THE COMPLAINT. CORRECTION: REPLACEMENTS HAVE BEEN PROVIDED ON ORDER #(B)(4). ROOT CAUSE ANALYSIS: THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION, BUT PICTURES WERE PROVIDED. IT WAS IDENTIFIED THAT ONE OF THE "WINGS" OF THE DEVICE THAT INSERTS INTO THE LUMEN WAS BROKEN. WITHOUT THE ACTUAL SAMPLE FOR EVALUATION, A TRUE ROOT CAUSE IS UNDETERMINED, BUT A PROBABLE ROOT CAUSE WAS IDENTIFIED AS END USER ERROR DUE TO OVERTIGHTENING OF THE DEVICE WITHIN THE SYRINGE. CORRECTIVE ACTION AND/OR SYSTEMIC ACTION TAKEN: DUE TO THE INVESTIGATION AND ROOT CAUSE FINDINGS, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. PREVENTIVE ACTION: DUE TO THE INVESTIGATION AND ROOT CAUSE FINDINGS, A PREVENTIVE ACTION HAS NOT BEEN TAKEN.

    Description of Event or Problem · 1

    THERE WAS A CRACK OR SPLIT IN THE "HUB" OF THE CATHETER. THE FLUSH STREAM WAS COMING OUT OF THE HUB OF THE DISTAL LUMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259256 TD CATHETER 5FR, 4 LUMEN, HEP CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1