BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-PACK II NEEDLE 27G & 30G THIN WALL

    MDR report key: 9443400 · Received December 10, 2019

    Report

    Report Number
    9681413-2019-00002
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    October 29, 2019
    Report Date
    December 10, 2019
    Manufacturer
    TERUMO EUROPE N.V
    Product Code
    FMI
    UDI-DI
    04987350700063
    PMA / PMN Number
    K110850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D10, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS INITIALLY REPORTED TO NOT BE AVAILABLE; HOWEVER, WAS RECEIVED FOR EVALUATION. A CORRECTION TO SECTION D4. UNIQUE IDENTIFIER (UDI)# IS BEING PROVIDED. THE INCORRECT UDI NUMBER WAS INADVERTENTLY SUBMITTED ON THE INITIAL REPORT; THEREFORE, THE CORRECT UDI# IS BEING PROVIDED. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A RED CONTAMINATION WAS FOUND IN THE HUB. TO IDENTIFY THIS FOREIGN MATTER, IDENTIFICATION THROUGH IR WAS TRIED; HOWEVER, IT WAS NOT POSSIBLE TO REMOVE THE RED PARTICLES FROM THE HUB. A FLUSH TEST WAS PERFORMED. DURING THIS TEST THE FOREIGN MATTER WAS TRIED TO BE REMOVED BY FLUSHING THE NEEDLE WITH MILLIQ WATER. HEREAFTER, THE RED CONTAMINATION WAS GONE AND THERE WAS NOTHING PRESENT IN THE WATER. THIS MEANS THAT THE CONTAMINATION WAS SOLUBLE IN WATER AND IT WAS NOT EMBEDDED INTO THE MATERIAL. THE BATCH RECORDS HAVE BEEN REVIEWED OF 1810040: MOULDING HUB- EQUIPMENT (MACHINE/MOULD): NN23/1944; DATE: (B)(6) 2018-(B)(6) 2018 AND (B)(6) 2018-(B)(6) 2018. NEEDLE ASSEMBLY- DATE: (B)(6) 2018-(B)(6) 2018 AND (B)(6) 2018-(B)(6) 2018. PACKAGING- EQUIPMENT: KPIIC; DATE: (B)(6) 2018-(B)(6) 2018. AS PART OF THE FINAL INSPECTION PROCESS, (B)(4). DURING NONE OF THE PRODUCTION STEPS DESCRIBED ABOVE, A SIMILAR DEFECT WAS OBSERVED DURING PRODUCTION. NO DEVIATIONS OR ABNORMALITIES RELATED TO YOUR COMPLAINT WERE NOTED DURING PRODUCTION. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IF THIS CONTAMINATION WAS CAUSED BY TERUMO, THE SOLVENT OF IVF-M HP WOULD HAVE REMOVED IT DURING USE. AS THE COMPLAINT SAMPLE WAS ALREADY USED, IT IS LIKELY THAT THIS WAS CAUSED AFTER THE INJECTION TO THE PATIENT. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THERE WAS A RED FOREIGN MATTER WAS OBSERVED IN THE HUB OF THE INVOLVED NEEDLE K-PACK II 30GX 1/2''-0,3X12MM-THIN WALL-SHORT CASE. THERE WAS NO HARM TO THE PATIENT. THE EVENT OCCURRED PRE-TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 19NOV2019. ONE CASE HAPPENED AMONG 90,000 PIECES. ADDITIONAL INFORMATION WAS RECEIVED ON 22NOV2019. THERE WAS NO DELAY, NO IMPACT ON PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241974 K-PACK II NEEDLE 27G & 30G THIN WALL NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO EUROPE N.V KN-3013RBKT 1810040 04987350700063

    Patients

    Seq Age Sex Outcome Treatment
    1 SYRINGE.