BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVELIFE

    MDR report key: 8064049 · Received November 13, 2018

    Report

    Report Number
    9618003-2018-03312
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EZQ
    UDI-DI
    00768455179213
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORD REVIEW: LOT 8D00477 WAS MANUFACTURED ON 04/17/2018 IN THE GUARD LINE WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 02/08/2019 TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BOM (BILL OF MATERIALS), DS10-034 (SYSTEM 5 DRAINABLE OSTOMY POUCH WITH STOMAHESIVE SKIN BARRIER), PROCESS INSTRUCTIONS (POUCH DISC COLLAR ASSEMBLY SYSTEM 5 B (GUARD MACHINE), AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT, UNDER INTERNATIONAL COMMODITY CODE (ICC) CODE 22767 SYSTEM APPLICATION PRODUCT (SAP) MATERIAL IDENTIFICATION (ID) 1003062 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. PHOTO/SAMPLE ANALYSIS: NO PHOTOS/SAMPLES WERE RECEIVED RELATED TO THE REPORTED PROBLEM. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION FINDINGS THROUGH REVISION OF THE BATCH RECORDS DOCUMENTATION, PROCESS OBSERVATION, PERSONNEL INTERVIEWED, METHODOLOGY IMPLEMENTED AND DEFECTS SIMULATION, THE ROOT CAUSE COULD NOT BE IDENTIFIED. NEVERTHELESS, THERE IS ONE (1) CONDITION THAT COULD BE CONSIDERED, BASED ON OBJECTIVE EVIDENCE, AS A CONTRIBUTOR FACTOR FOR THIS EVENT: THERE IS NOT CONTROL IN PLACE FOR CENTERING PINS IN THE GUARD LINE. NO ISSUES RELATED TO MACHINE, MATERIAL, METHOD, MEASUREMENT OR ENVIRONMENT WERE IDENTIFIED DURING THE MANUFACTURING PROCESS EVALUATION, THEREFORE NO FURTHER ACTIONS ARE REQUIRED RELATED TO THESE FACTORS. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER. REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRECUT STARTER HOLES IN THE MASS WERE CUT OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902738 ACTIVELIFE POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC INC 022767 8D00477 00768455179213

    Patients

    Seq Age Sex Outcome Treatment
    1 Female