BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELI

    MDR report key: 10680764 · Received October 14, 2020

    Report

    Report Number
    1058382-2020-00002
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Report Date
    November 16, 2020
    Manufacturer
    MICSAFE MEDICAL GROUP (CHINA) CO., INC.
    Product Code
    GAA
    UDI-DI
    00386120007205
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F7 - UPDATED TO INDICATE THIS IS A SUPPLEMENTAL / FOLLOW-UP REPORT (001). H10: ADDITIONAL NARRATIVE FROM IMPORTER: WE ARE MOVING TO CLOSE THIS COMPLAINT BASED ON THE RESULTS OF THE CUSTOMER AUDIT OF THE FACTORY(1), CORING TESTING RESULTS COMPLETED DURING THE AUDIT(2), AND THE MANUFACTURER'S INVESTIGATION RESULTS(3). A SUMMARY OF THESE RESULTS IS BEING PROVIDED FOR YOUR INFORMATION. [1.] CUSTOMER AUDIT - HEALTHTRUST CHINA SOURCING TEAM MEMBER MR. (B)(6) CONDUCTED AN ON-SITE AUDIT OF THE BATCH RECORDS FOR THIS BATCH, AND SEVERAL OTHER BATCHES BOTH THOUGHT TO BE RECEIVED BY THE FACILITIES AND IN CURRENT PRODUCTION. HE REPORTED THAT THERE WERE NO CHANGES MADE TO THE RAW MATERIALS USED TO MAKE THE DEVICE, PRODUCTION PROCESSES AND MACHINES, OR STAFF INVOLVED WITH THE MANUFACTURE AND INSPECTION OF THE DEVICE DURING AND AFTER PRODUCTION. HE NOTED THIS PRODUCT IS PRODUCED LARGELY BY AUTOMATION, AND ALL SYSTEMS WERE COMPLIANT. THE DHR FOR THE INSPECTED LOTS MET THE REQUIREMENTS OF THEIR DOCUMENTED PROCEDURES. [2.] THE FACTORY CONDUCTED A CORING TEST USING A TEST PROTOCOL PRE-APPROVED BY HEALTHTRUST, AND WAS OBSERVED BY THE HEALTHTRUST AUDITOR, MR. (B)(6). FIFTY (50) PIECES OF RETAIN SAMPLES FROM THE SUSPECT BATCH (LOT#: 191030) WERE TESTED, FIFTY (50) PIECES OF RETAIN SAMPLES FROM LOT#: 190825, AND SIX HUNDRED (650) PIECES OF LOT#: 20201026 WHICH WERE CURRENTLY IN PRODUCTION. THE FACTORY TEST RESULT SPECIFICATION ALLOWS THREE (3) OCCURRENCES OF CORING PER ONE HUNDRED (100) TESTED SAMPLES. THE FACTORY CONDUCTED THE TESTING USING THREE HUNDRED (300) TEST VIALS AND NOTED ONE (1) OCCURRENCE OF CORING FROM THE IN-PROCESS BATCH (LOT#: 20201026). NO CORING WAS OBSERVED DURING THE TESTING OF THE SUSPECT BATCH (LOT#: 191030) OR THE OTHER MYCO BATCH TESTED (LOT#: 190825). THERE WAS NO EVIDENCE OF A QUALITY ISSUE WITH THE DEVICE FROM THE TESTING RESULT, AND THEY CONCLUDE THE ONE (1) OCCURRENCE OF CORING NOTED DURING TESTING MAY BE CAUSED BY A PROBLEM WITH THE RUBBER STOPPER OF THE VIAL. [3.] THE MANUFACTURER CONCLUDED THE RELI® BLUNT FILL NEEDLE MET ALL MATERIAL AND PERFORMANCE SPECIFICATIONS, THERE WAS NO QUALITY ISSUE WITH THE DEVICE, AND NO CORRECTIVE ACTION IS NECESSARY. THE FACTORY TEST REPORT HAS BEEN ATTACHED TO THIS REPORT. WE CONSIDER THIS REPORT CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INJECTING AIR AND IN THE PROPOFOL VIAL AND WITHDRAWING THE DRUG, A DARK FLEK WAS VISIBLE IN THE EMPTY VIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INJECTING AIR AND IN THE PROPOFOL VIAL AND WITHDRAWING THE DRUG, A DARK FLEK WAS VISIBLE IN THE EMPTY VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146003 RELI BLUNT FILL NEEDLE GAA MICSAFE MEDICAL GROUP (CHINA) CO., INC. BFN18G151 190530 00386120007205

    Patients

    Seq Age Sex Outcome Treatment
    1