BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE FOLEY 2WAY 12X05

    MDR report key: 4945130 · Received July 24, 2015

    Report

    Report Number
    9611710-2015-00121
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Report Date
    July 10, 2015
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    EZL
    PMA / PMN Number
    K010420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: BASED ON THE LOT NUMBER PROVIDED BY THE CUSTOMER, THE ASSEMBLY WORK ORDER WAS REVIEWED AND REVEALED NO SIGN OF ASSOCIATED DEFECTS DURING THE 100% INSPECTION AND LIGHT TEST. INCOMING INSPECTION REPORT WAS REVIEWED AND DID NOT REVEAL ANY SIGN OF SUCH DEFECT(MIXED PRODUCT). THE LOT WAS CONSIDERED ACCEPTABLE UPON RELEASE. PICK SLIP AND BATCH RECORDS REVEALED THAT THE SCN CATHETER WAS ISSUED FOR ASSEMBLY PROCESS. IN REVIEWING THE THE COMPLETION LOG SHEET IT REVEALED THAT THERE WAS SIZE FG16 AND FG12 COMPLETED ON THE SAME DAY. THE REVIEW OF MANUAL POUCHING RECORD SHOW THE SIZE FG12 WAS BACK ON 03/18/2015 AND SIZE FG16 WAS PACKED ON 03/14/2015. THUS, NO POTENTIAL FOR MIXED LOTS. REVIEW OF THE PRINTING LOG BOOK REVEALED THAT LABEL FOR SIZE FG16 WAS PRINTED ON 03/14/2015 AND 03/26/2015. FG12 WAS PRINTED ON 03/18/2015, NO POTENTIAL FOR MIX-UP. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVALUATION, BUT WAS CONFIRMED BASED ON THE CUSTOMER FEEDBACK. AN INTERNAL NONCONFORMANCE WAS CREATED. THE COMPLAINT WILL REMAIN OPEN UNTIL COMPLETION OF THE INTERNAL NONCONFORMANCE. (B)(4). NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: A TOTAL OF TWO (2) COMPLAINTS ASSOCIATED WITH THIS COMPLAINT ISSUE. A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING WAS LABELED AS FG16 BUT, THE PRODUCT INSIDE THE PACKAGING WAS LABELED FG12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483406 SILICONE FOLEY 2WAY 12X05 CATHETER, RETENTION TYPE, BALLOON EZL UNOMEDICAL SDN BHD 907.421.0512 814438R001

    Patients

    Seq Age Sex Outcome Treatment
    1