BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5 CM BIOPATCH WITH 7.0 MM CENTER HOLE WITH MULTILINGUAL IFU

    MDR report key: 7314189 · Received March 5, 2018

    Report

    Report Number
    3004608878-2018-00027
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Date of Event
    December 3, 2017
    Report Date
    February 22, 2018
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    K003229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON APRIL 19, 2018: HOW MANY SAMPLES WERE TESTED DURING EACH STERILITY TEST. HOW MANY SAMPLES FAILED? 2 WHAT WAS THE METHODOLOGY USED FOR THE TESTING? UNKNOWN. LABORATORY THAT PERFORMED TESTING QC MOH AUTHORITY. LABORATORY INVESTIGATION QC MOH AUTHORITY. TEST CONTROLS RESULTS, AREA ENVIRONMENTAL CONTROLS, TECHNIQUES USED. UNKNOWN. REASON FOR THE TESTING AS PER EGYPT MOH REGULATIONS 1ST SHIPMENT OF STERILE REGISTERED PRODUCTS WILL BE SAMPLED AND TESTED BY QC MOH AUTHORITY. RATIONALE FOR RETESTING, BASED ON USP THE STERILITY TESTING CAN BE REPEATED ONLY UNDER SPECIAL CIRCUMSTANCES WHERE THERE IS INDICATION OF A LABORATORY ERROR. WHY A RETEST WAS DONE? FAILURE OF THE FIRST TESTING. MICROORGANISMS IDENTIFICATION UNKNOWN. LOT DISTRIBUTION INFORMATION (ALL LOT SENT TO SPECIFIC LOCATION? ALL LOT DISTRIBUTED? QTY SENT TO EACH END USER OR CUSTOMER). LABORATORY ENVIRONMENTAL, PERSONNEL TRAINING AND ALL OTHER ELEMENTS OF A LAB INVESTIGATION UNKNOWN. WHY THE TEST WAS REPEATED; FAILURE OF THE FIRST STERILITY TEST . LOT DISTRIBUTION DATES, WHERE THE TESTED SAMPLES WERE STORED AFTER DISTRIBUTION AND BEFORE TESTING. DISTRIBUTOR-QUARANTINE. SAMPLES EVALUATION BEFORE TESTING. NA . ANY OTHER TESTING CONDUCTED? POTENCY? UNKNOWN. HAVE THE TEST BEING CONDUCTED BEFORE? FIRST TIME CONDUCTING THE TESTING? AS PER EGYPT MOH REGULATIONS 1ST SHIPMENT OF STERILE REGISTERED PRODUCTS WILL BE SAMPLED AND TESTED BY QC MOH AUTHORITY. INVESTIGATION FINDINGS: DOCUMENTATION REVIEW OF REPORTED LOT 1165816 (INCLUDING STERILIZATION CYCLE SPS-177 / LOT: LE-16401) DID NOT REVEAL ANY ANOMALIES THAT COULD CAUSE THE REPORTED STERILITY TESTING FAILURE. NO EVENT, NON-CONFORMANCE AND/OR REWORK WAS RECORDED FOR THE MENTIONED LOT; THEREFORE, IT IS CONCLUDED THAT THE LOT COMPLIED WITH ALL IN-PROCESS INSPECTIONS AND TESTING REQUIREMENTS AS SPECIFIED IN THE MANUFACTURING BATCH RECORD AND RELATED PROCEDURES. RETAIN SAMPLES WERE EVALUATED. VISUAL INSPECTION WAS PERFORMED TO 100 RETAIN SAMPLES. ALL SAMPLES HAD NORMAL APPEARANCE AND COLOR (WHITE ¿ NO DISCOLORATION WAS OBSERVED). SEALING AREA WAS ALSO INSPECTED FOR EACH UNIT. ALL UNITS WERE FOUND TO BE SEALED COMPLETELY WITHOUT ANY VOIDS ACROSS THE SEAL WIDTH. FORTY (40) SAMPLES WERE DELIVERED TO THE MICROBIOLOGY LABORATORY FOR STERILITY TESTING. THE SAMPLES WERE SENT TO AN APPROVED EXTERNAL LABORATORY FOR TESTING. TEST RESULTS WERE RECEIVED INDICATING THE SAMPLES SHOWED NO-GROWTH AFTER 14 DAYS OF INCUBATION; THUS, MEETING THE REQUIREMENTS OF USP¿40 <70> FOR STERILITY. THE COMPLAINT IS CONSIDERED NOT CONFIRMED. ROOT CAUSE: THIS INVESTIGATION REPORT HAS NOT FOUND ANY INDICATION THAT THE REPORTED STERILITY FAILURE WAS CAUSED BY ANY OF THE PROCESSES PERFORMED AT INTEGRA. THERE ARE VALIDATED CONTROLS THAT ENSURE ALL PRODUCTS ARE SOLD STERILE AS PER CURRENT PROCESSES AND PROCEDURES.

    Additional Manufacturer Narrative · 0

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION: ALL BOXES WERE OPENED AND EACH UNIT WAS VISUALLY EVALUATED. SOME SPONGES WERE FOUND TO BE SLIGHTLY DISCOLORED (OFF-WHITE); NONETHELESS, AS STATED IN THE IFU, ¿OVER TIME THE BIOPATCH MAY TURN YELLOW IN COLOR. THIS COLORATION DOES NOT REDUCE THE ANTIMICROBIAL EFFICACY OF THE DRESSING.¿ SEALING AREA WAS ALSO INSPECTED FOR EACH UNIT (1,919 POUCHES). ALL UNITS WERE FOUND TO BE SEALED COMPLETELY WITHOUT ANY VOIDS ACROSS THE SEAL WIDTH. NO ADDITIONAL TESTS WERE REQUESTED SINCE STERILITY TESTING HAD ALREADY BEEN PERFORMED TO THE RETAIN SAMPLES WHICH ARE REPRESENTATIVE OF THE LOT. THERE ARE NO CHANGES TO THE CONCLUSIONS AS ORIGINALLY REPORTED BASED ON THE OBSERVATIONS MADE FROM VISUAL INSPECTION OF THE RETUNED UNITS.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT FAILED LAB STERILITY TEST TWICE AND WAS DEEMED SUB-STANDARD BY DISTRIBUTOR IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157423 2.5 CM BIOPATCH WITH 7.0 MM CENTER HOLE WITH MULTILINGUAL IFU BIOPATCH FRO INTEGRA NEUROSCIENCES PR 1165816

    Patients

    Seq Age Sex Outcome Treatment
    1