BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK SG3

    MDR report key: 6763978 · Received August 3, 2017

    Report

    Report Number
    3003902955-2017-00018
    Event Type
    Malfunction
    Date Received
    August 3, 2017
    Report Date
    August 3, 2017
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    MEG
    PMA / PMN Number
    K113422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI - NOT AVAILABLE DUE TO UNKNOWN PRODUCT CODE/LOT NUMBER COMBINATION. D11: CONCOMITANT MEDICAL PRODUCTS. DETAILS: RISPERDAL CONSTA DRUG KIT W/ SG3+2125 & SG3+2051 FOR DELTOID/GLUTEAL INJECTION OF RISPERDAL CONSTA DRUG SUSPENSION. THE PART AND LOT NUMBER IS UNKNOWN FOR THIS COMPLAINT. THE FOLLOWING LOT NUMBERS WERE REPORTED AS POTENTIALLY INVOLVED IN THE REPORTED COMPLAINT: (1) SG3+2051 LOT NO. 141018C (2) SG3+2051 LOT NO. 150127C (3) SG3+2051 LOT NO. 150428C (4) SG3+2051 LOT NO. 150508C (5) SG3+2125 LOT NO. 160114D (6) SG3+2125 LOT NO.160116D. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED FOR INVESTIGATION, WE CANNOT PROVIDE DETAILED INFORMATION OF THE ACTUAL CONDITION OF THE COMPLAINT SAMPLE. THE RETENTION SAMPLES OF THE POTENTIAL LOTS WERE VISUALLY INSPECTED AND REVEALED NO DEFECTS. THERE WERE NO DAMAGES OR CRACKS ON THE SHEATH AND COLLAR. THE SAFETY SHEATH IS PROPERLY ASSEMBLED AND THE COLLAR IS FULLY SEATED ON THE HUB. THE SUPPLIED SG3 SHEATH, COLLAR AND HUB (AS RAW MATERIAL) HAD UNDERGONE IN-PROCESS VISUAL INSPECTION DURING MOLDING PROCESS OF SG3 SHEATH, COLLAR AND HUB EVERY HOUR TO CHECK THE OVERALL APPEARANCE OF THE MOLDED PARTS. BASED ON OUR RECORDS, NO NON-CONFORMITIES WERE NOTED. DURING MANUAL ASSEMBLY OF SAFETY SHEATH, WE HAVE IN-PROCESS INSPECTION FOR VISUAL, SENSORY TEST AND FUNCTIONAL TEST TO ASSURE QUALITY PERFORMANCE OF ASSEMBLED NEEDLE. THERE WERE NO NON-CONFORMITIES NOTED THAT MAY LEAD TO BREAKAGE OF THE SHEATH AND COLLAR BASED ON OUR RECORDS. SHEATH LUGS ARE CHECKED IF FIRMLY ATTACHED TO THE COLLAR EARS THROUGH COMPONENT FIT AND HINGE MOTION FORCE TEST AS PER INSTRUCTION FOR USE. MANUAL ACTIVATION OF THE SHEATH IS PERFORMED TO CHECK PERFORMANCE OF DEVICE DURING ACTIVATION. BASED ON THE INSPECTION RESULTS, ALL SAMPLES PASSED. THE SG3 SAFETY DEVICE WAS DEVELOPED WITH FEATURES SUCH AS CIRCULAR DENT FOR EASY ACTIVATION USING THE THUMB. IN ADDITION, THERE IS EVEN THICKNESS OF COLLAR EAR FOR A SECURE SHEATH-COLLAR FITTING THUS PREVENTING SHEATH FROM BREAKING OFF. THE COLLAR ARMS AND SHEATH WINGS LOCK FOR SAFETY LOCKING MECHANISM. SIMULATION WAS CONDUCTED USING RETENTION SAMPLES OF POTENTIAL LOTS FOR MANUAL SHEATH ACTIVATION. THE SAFETY SHEATH WAS SUCCESSFULLY ACTIVATED. NO BROKEN SHEATH WAS ENCOUNTERED. AN AUDIBLE CLICK SOUND WAS HEARD AND THE CANNULA WAS FULLY ENGAGED UNDER THE TOOTH UPON VISUAL CONFIRMATION. A LOT HISTORY FILE REVIEW WAS CONDUCTED WITH NO RELEVANT FINDINGS. PRIOR TO SHIPMENT, QC CONDUCTS OUTGOING VISUAL INSPECTION AND ALL SAMPLES FOR THE COMPLAINT LOT PASSED. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION AND THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION FROM THE USER FACILITY AND INVESTIGATION RESULTS. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO (PHILIPPINES) CORPORATION (MANUFACTURER) REGISTRATION NO. 3003902955. EXEMPTION NUMBER E2015017. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED BREAKAGE WITH THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED: PHARMACIST ADMINISTERED A DOSE OF RISPERDAL CONSTA TO A PATIENT; WHEN HE ATTEMPTED TO CLOSE THE SAFETY SHIELD THE NEEDLE SNAPPED OFF; THE PHARMACIST WAS STUCK WITH THE USED NEEDLE; AND THE PHARMACIST REPORTED AS TREATMENT HE CLEANED THE AREA AND WILL GO TO A URGENT CARE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE ADDITIONAL INFORMATION TO EVENT AND TO INCLUDE PHOTOGRAPHIC INSPECTION. A PHOTOGRAPH WAS SENT TO THE MANUFACTURING FACILITY FOR EVALUATION. THE PHOTO REVEALED 1 NON-TERUMO PIECE GLASS SYRINGE AND A 20-GAUGE SAFETY NEEDLE. THE SAFETY NEEDLE WAS ALREADY ACTIVATED AND THE SYRINGE TIP WAS BROKEN WITH THE DAMAGED PART REMAINING ON THE NEEDLE HUB. BASED OFF THE REFERENCED PHOTO PROVIDED, IT IS LIKELY EXCESSIVE FORCE WAS APPLIED DURING ACTIVATION OF THE SAFETY NEEDLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 10, 2017. WHEN IT BROKE, THE DEVICE FLEW INTO THE AIR AND THE NEEDLE POKED THE PHARMACISTS IN THE SHOULDER BEFORE ACTIVATING THE NEEDLE SAFETY GUARD. THE ACTIVATION METHOD WAS FLAT ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546340 UNK SG3 SYRINGE, ANTISTICK MEG TERUMO PHILIPPINES CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RISPERDAL CONSTA DRUG KIT.| RISPERDAL CONSTA DRUG KIT.