BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEBASICS SALIVA EJECTOR

    MDR report key: 6281928 · Received January 26, 2017

    Report

    Report Number
    9611959-2017-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2017
    Date of Event
    December 5, 2016
    Report Date
    January 26, 2017
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    DYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT WAS REPORTED TO AMD MEDICOM INC. ON 05-DEC-2016 FOR MEDICOM BRAND PRODUCT SALIVA EJECTOR ITEM CODE# 700 LOT NUMBER #100.16. THE MASK IS CLASSIFIED AS A CLASS 1 DEVICE, UNDER FDA CODE DYN, WHOSE INTENDED USE IS TO SUPPLY POWER TO AND SERVE AS A BASE FOR OTHER DENTAL DEVICES, SUCH AS A DENTAL HAND PIECE, A DENTAL OPERATING LIGHT, AND AN AIR OR WATER SYRINGE UNIT, AND ORAL CAVITY EVACUATOR, A SUCTION OPERATIVE UNIT, AND OTHER DENTAL DEVICES AND ACCESSORIES. THE DEVICE MAY BE ATTACHED TO DENTAL CHAIR. THE FOLLOWING INFORMATION WAS INITIALLY REPORTED: "SALIVA EJECTOR TIP FELL OFF POSSIBLY IN PATIENT AND TIPS ARE LOOSE AND NOT STAYING ON. FIRST TIME THIS HAPPENED. CLIENT HAS BEEN USING THE PRODUCT FOR YEARS" ON 07-DEC-2016 CLIENT WAS CONTACTED BY AMD MEDICOM BY PHONE FOR FURTHER INFORMATION. (B)(6) FROM THE (B)(6) HOSPITAL ANESTHESIA DEPARTMENT MENTIONED THAT THE PATIENT WAS UNDERGOING AN ENDOSCOPY PROCEDURE WHEN THE INCIDENT HAPPENED. THEY ARE STILL UNSURE IF THE TIP FELL OFF INTO THE PATIENT BUT THEY COULD NOT LOCATE THE TIP ANYWHERE AND HE BELIEVES THERE IS A CHANCE THAT THE TIP WAS SWALLOWED BY THE PATIENT. HE MENTIONED THE PATIENT WOULD HAVE SYMPTOMS IF THEY ASPIRATED THE TIP INTO THE LUNGS. HE CONFIRMED THAT THE PATIENT HAD NO SYMPTOMS. HE MENTIONED THAT THE TIPS ARE NORMALLY STORED IN THE BAGS ON A SHELF IN THE HOSPITAL. THE COMPLAINT RECEIVED BY AMD MEDICOM HAS BEEN LOGGED AS A PRODUCT QUALITY COMPLAINT UNDER (B)(4). A REQUEST FOR INVESTIGATION WAS MADE TO THE MANUFACTURING FACILITY, THROUGH CAPA (B)(4). INVESTIGATION: - REVIEW OF AMD MEDICOM QUALITY COMPLAINT RECORDS CONFIRMED THAT NO SIMILAR ISSUES HAD BEEN REPORTED FOR ITEM CODE # 700, UNDER LOT # 100.16. - RETAIN SAMPLES WERE INSPECTED BY AMD MEDICOM. THE BLUE CAP WAS NOT EASILY REMOVABLE. - RETURN SAMPLES WERE RECEIVED FROM END-USER RELATED TO THE NATURE OF THE COMPLAINT. SIXTY (60) UNITS (I.E. SALIVA EJECTORS) WERE RECEIVED AND INSPECTED, ONLY 09 UNITS HAD BLUE CAP THAT WERE POTENTIALLY REMOVABLE WHEN MANIPULATED. - RETURN SAMPLES WERE SENT TO THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. ROOT CAUSE: - THE ROOT CAUSE WAS IDENTIFIED TO BE RELATED TO LINE CLEARANCE. SOME REMOVABLE TIPS FROM THE PREVIOUS PRODUCTION WERE NOT REMOVED FROM THE PRODUCTION LINE. CORRECTIVE ACTIONS: - DURING EVERY PRODUCTION CHANGE FROM THE MANUFACTURE OF REMOVABLE TO FIXED TIPS, FIRST TWO MINUTES OF PRODUCTION NEEDS TO BE REMOVED FROM THE PRODUCTION LOT. -THE MANUFACTURING FACILITY PROCEDURE MDQ/8.2.4/A "PRODUCTS MONITORING AND MEASUREMENT" HAS BEEN UPDATED TO REFLECT THIS CHANGE. IN CONCLUSION, THE RISK ASSOCIATED TO THE NATURE OF COMPLAINT IS CONSIDERED LOW IF IT IS A SHORT TERM EXPOSURE TO PVC WHICH IS THE MATERIAL THE SALIVA EJECTORS ARE MADE OF. FURTHERMORE, NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN REPORTED FOR THIS PRODUCT AND LOT NUMBER.

    Description of Event or Problem · 1

    SALIVA EJECTOR TIP FELL OFF POSSIBLY IN PATIENT AND TIPS ARE LOOSE AND NOT STAYING ON. FIRST TIME THIS HAPPENED. BEEN USING THE PRODUCT FOR YEARS. NOTED SEVERAL IN THIS PACKAGE THAT TIP EASILY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62021 SAFEBASICS SALIVA EJECTOR SALIVA EJECTOR DYN AMD MEDICOM INC. 100.16

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other