BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLONCARE

    MDR report key: 5814209 · Received July 21, 2016

    Report

    Report Number
    9611959-2016-00001
    Event Type
    Malfunction
    Date Received
    July 21, 2016
    Date of Event
    September 17, 2015
    Report Date
    July 20, 2016
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT WAS REPORTED FOR BRAND PRODUCT SOLON 6IN COTTON TIPPED APPLICATORS (CTA) PLASTIC PRODUCT CODE# 56201 IN WHICH THE FOLLOWING INFORMATION WAS INITIALLY REPORTED: "CUSTOMER REPORTED ISSUE WITH THEIR LAP GENERAL TRAY, COMPONENT COTTON APPLICATOR TIP FELL OFF INSIDE OF PATIENT". THE APPLICATOR IS CLASSIFIED AS A CLASS 1 DEVICE, UNDER FDA CODE KXG WHOSE INTENDED USE IS AS FOLLOW: TO APPLY MEDICATIONS TO, OR TO TAKE SPECIMENS FROM, A PATIENT. THE COMPLAINT WAS RECEIVED ON 17-SEP-2015 AND LOGGED AS FINISHED PRODUCT QUALITY COMPLAINT (B)(4). A REQUEST FOR INVESTIGATION WAS MADE TO THE MANUFACTURING FACILITY BASED ON THE INFORMATION RECEIVED AT THAT TIME. NO OTHER COMPLAINT OF THIS NATURE WAS REPORTED . IN ADDITION, THE COTTON BUD WAS REMOVED WITH NEITHER PATIENT INJURY NOR ADDITIONAL MEDICAL INTERVENTION BEING REPORTED. AT THE TIME OF RECEPTION OF THE QUALITY COMPLAINT, AN EVALUATION WAS PERFORMED AND IT WAS DEEMED THAT ADDITIONAL INFORMATION WAS REQUIRED. A QUESTIONNAIRE WAS FORWARDED TO THE COMPLAINANT ON 21-SEP-2015. ANY MEDICAL INTERVENTION REQUIRED? WHICH PROCEDURE WAS FOLLOWED TO USE THE PRODUCT? ANY PARTICULAR OBSERVATIONS NOTICED RELATED TO THIS INCIDENT? THE COMPLAINANT INDICATED, ON 22-SEP-2015, THAT PREVIOUSLY MULTIPLE ATTEMPTS HAD BEEN MADE (I.E. AT LEAST 4 EMAILS AND 2 PHONE CALLS SINCE (B)(6) 2015) TO OBTAIN CLINICAL DATA FROM THE END-USER. IT WAS COMMUNICATED BY THE END USER THAT DUE TO THE TIME AT WHICH THE EVENT TOOK PLACE (OFF-HOURS) IT WAS DIFFICULT TO OBTAIN ANY FURTHER INFORMATION/CLARIFICATION FROM END-USER PRESENT AT THE TIME OF THE EVENT. THE ONLY ADDITIONAL INFORMATION COMMUNICATED BY THE END USER AND PROVIDED ON 12-OCT-2015 WAS THAT THE "COTTON-TIPPED APPLICATOR FELL OFF INSIDE PATIENT DURING GENERAL LAPAROSCOPY". NO FURTHER CLARIFICATION/INFORMATION WAS PROVIDED. SINCE, NO FURTHER DETAILS WERE TO BE RECEIVED, THE INVESTIGATION WAS PERFORMED BY THE MANUFACTURING FACILITY (B)(6) BASED ON THE AVAILABLE INFORMATION: REVIEW OF THE DHR INDICATED THAT COMPLAINED PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH CURRENT PROCEDURES AND INTERNAL SPECIFICATIONS. NO DEVIATIONS WERE NOTED DURING THE MANUFACTURING PROCESS. PRODUCT COMPLIES WITH REQUIREMENT FOR "BUD TIGHTNESS "INSPECTION AS PER FINISHED PRODUCT SPECIFICATION. PRODUCTION PROCESS OF CTA PLASTIC ITEM CODE# 56201 IS AS FOLLOW: SHAFTS ARE HEATED BY MACHINE AND ARE SCORED (USUALLY 3 CIRCLES) INITIALLY AT ONE END OF THE SHAFT, THEN PROCEEDS TO THE NEXT STEP IN THE MANUFACTURING PROCESS WHEREBY THE COTTON IS WINDED TO THE SHAFT. PROBABLE CAUSE FOR LOOSE BUD WOULD BE THAT THE SCORES FOR THIS APPLICATOR WERE NOT DEEP ENOUGH TO HOLD THE BUDS TIGHTLY. BASED ON THE ABOVE INVESTIGATION THE FOLLOWING CORRECTIVES/ PREVENTIVES ACTIONS WERE IMMEDIATELY IMPLEMENTED: INFORM ALL PRODUCTION OPERATORS, PRODUCTION SUPERVISORS AND QC INSPECTORS OF THE NATURE OF THE COMPLAINT. IMPROVE THE MANUFACTURING PROCESS; WHEREBY MEDICAL GRADE GLUE IS ADDED TO THE SHAFT WHICH HAS BEEN INITIALLY SCORED PRIOR TO WINDING THE COTTON TO THE SHAFT. RE-TRAIN THE OPERATORS AND INSPECTORS ON THE NEW PROCESS. EMPHASIS ON DAILY VERIFICATION DURING THE PRODUCTION AND QUALITY INSPECTION PROCESS, TO AVOID NON- CONFORMING PRODUCTS BEING PACKED. IN ADDITION TO THE ACTIONS IMPLEMENTED BY (B)(6)., (B)(4) DECIDED TO TIGHT ITS INSPECTION LEVEL OF ITS FINISHED PRODUCT PRIOR TO RELEASE AS INDICATED BELOW: INCREASE SINGLE SAMPLING PLAN FROM NORMAL TO TIGHTENED INCREASE INSPECTION LEVEL FROM S4 TO GI. IT SHOULD BE NOTED THAT AT THIS TIME, NO OTHER COMPLAINTS OF THIS NATURE HAS BEEN REPORTED FROM ANY OTHER USERS WHICH CONFIRMED THE EFFECTIVENESS OF THE CORRECTIVE ACTIONS IMPLEMENTED. NOT RETURNED BY END-USER FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUE WITH THEIR LAP GENERAL TRAY. COMPONENT COTTON TIP APPLICATOR FELL OFF INSIDE A PATIENT. NO PATIENT INJURY CUSTOMER HAS INDICATED THAT A SAMPLE IS NOT AVAILABLE FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467332 SOLONCARE NON-STERILE COTTON TIP APPLICATOR KXF AMD MEDICOM INC. 67209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other