BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA TDC VITRECTOMY PACK VGPC INPUT 25G

    MDR report key: 8219303 · Received January 4, 2019

    Report

    Report Number
    1222074-2019-00003
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
    Product Code
    QDY
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 28-12-2018: DORC HAS RECEIVED THREE COMPLAINTS RELATED TO THE INTEGRITY OF THA PACKAGING: (B)(4). THE INVESTIGATION OF THE COMPLAINTS WAS COMBINED. THE ANALYSES OF THE RESULTS OF THE INVESTIGATION WAS AS FOLLOWS: THIS PACKAGING IS INDUSTRY-STANDARD TYVEK® AND PET-G TRAY, AND THE DESIGN WAS SUCCESSFULLY VALIDATED AND VERIFIED DURING THE DESIGN PROCESS AND SUBSEQUENT PERIODIC RE-VALIDATION. THE IN-PRODUCTION CONTROL IS DOCUMENTED IN THE BATCH RECORDS OF THE LOT OF THIS PRODUCT, NO RELEVANT ANOMALIES IN BATCH RECORDS HAVE BEEN FOUND. RELEVANT RECORDS FOR SEAL TENSILE STRENGTH TESTING (WHICH IS PERFORMED ON EVERY BATCH) SHOWED SEAL STRENGTHS WITHIN THE NORMAL DISTRIBUTION EXPECTED. ALL COMPLAINT SAMPLES OF THE CURRENT THREE COMPLAINTS USE THE SAME BATCHES OF TYVEK® AND PET-G TRAYS (THIS IS NOT UNEXPECTED, BATCHES ARE VERY LARGE AND CAN SPAN SEVERAL MONTHS OF PRODUCTION FOR DORC.) ALL BATCHES USED THE SAME SEALING PARAMETERS, WHICH WERE WITHIN THE VALIDATED SEALING WINDOW. IN ALL CASES, THE TYVEK® AND ASSOCIATED HOT-MELT ADHESIVE HAS BEEN INVESTIGATED AND SHOWS CLEAR EVIDENCE OF ADHESIVE HAVING BEEN NORMALLY MELTED. COMPLAINTS (B)(4) APPEAR TO SHOW A KNOWN PHENOMENA WITH THIS PACKAGING TYPE, SPECIFICALLY THE SEAL APPEARS TO HAVE EXHIBITED CREEP, LIKELY DURING THE STERILIZATION PROCESS. DURING THIS PROCESS, BOTH HIGH TEMPERATURE AND A PRESSURE DIFFERENTIAL (INTERNAL OF THE TRAY AT HIGHER PRESSURE TRANSIENTLY THAN THE CHAMBER) ARE MAINTAINED. ALTHOUGH THE POROSITY OF THE TYVEK® ALLOWS EQUALIZATION, IT IS KNOWN THAT THE SEAL CAN CREEP DURING THIS PROCESS. IT IS PARTLY FOR THIS REASON THAT A SEAL WIDTH OF 6MM IS SPECIFIED IN THE STANDARD. IN THESE TWO COMPLAINT SAMPLES, IT IS NOT POSSIBLE FROM VISUAL INSPECTION TO TELL IF THE CREEP THREATENED THE INTEGRITY OF THE SEAL. ADDITIONAL "TEST WERE" PERFORMED: 100 PACKS (FROM RETAINED, STERILIZED FINISHED PRODUCT MADE AT A SIMILAR TIME TO THE COMPLAINT SAMPLES, AND USING IDENTICAL SEALING PARAMETERS) WERE PEELED TO OBSERVE FOR ANY SEALING DEFECTS. IN A NUMBER OF CASES, PEELING "ARTEFACT'S" WERE NOTED. UPON DETAILED REVIEW (AND IN CONJUNCTION WITH THE MANUFACTURER OF THE PACKAGING) IT IS CONCLUDED THAT THESE "ARTEFACT'S" DO NOT REPRESENT SEAL INTEGRITY ISSUES. SUCH "ARTEFACT'S" REPRESENT LOCAL AREAS WHERE THE ADHESIVE IS PREFERENTIALLY RETAINED BY THE TYVEK® AND NOT THE PET-G. THIS SITUATION CAN BE CREATED BY PEEL ANGLE (THE RELATIVE ANGLE OF THE LID AND TRAY DURING PEELING), PEELING FORCE AND SPEED AND OTHER FACTORS. IT IS CONCLUDED THAT THE "ARTEFACT'S" SEEN DO NOT REPRESENT INTEGRITY ISSUES. THIS IS SUPPORTED BY REVIEW OF THE TYVEK ON THE SAMPLES DESCRIBED BELOW, WHERE IN ALL CASES THE ADHESIVE IS FULLY MELTED. THIS WOULD NOT BE THE CASE IN THE EVENT OF "COLD SPOTS" OR OTHER SEALING PROCESS ISSUES. THIS CONCLUSION IS FURTHER SUPPORTED AS SUBSEQUENT TO THIS PEEL TESTING, DYE PENETRATION TESTING WAS PERFORMED ON AN ADDITIONAL (B)(4) PACKS ACCORDING TO THE STANDARD METHOD. NO SEAL INTEGRITY ISSUES WERE OBSERVED. THIS SUGGESTS THAT NO ISSUES THREATENING THE INTEGRITY OF THE SEAL EXIST IN THESE PACKS. CONCLUSION: IN THE CASES OF (B)(4) IT REMAINS POSSIBLE THAT SEAL INTEGRITY WAS IMPACTED BY CREEP DURING THE STERILIZATION PROCESS. THIS CAN HAPPEN IN ANY STERILIZATION PROCESS. INVESTIGATION ON CONTEMPORARY PRODUCT OF THE SAME TYPE (FROM IDENTICAL BATCHES OF RAW MATERIALS AND SEALING CONDITIONS) DOES NOT HIGHLIGHT ANY SEAL INTEGRITY FAILURES VIA DYE PENETRATION, AND A REVIEW OF ALL BATCH RECORDS DOES NOT SHOW ANY SEAL STRENGTH MEASUREMENTS WHICH GIVE RISE TO CONCERNS OVER SEAL STRENGTH. IN THE CASE OF (B)(4) NO SIGNS OF CREEP ARE IDENTIFIED ON THE RETURNED MATERIAL. THE AVAILABLE EVIDENCE STRONGLY SUGGESTS THAT THE COMPLAINT RELATES TO A PEELING "ARTEFACT'S" AND IS NOT AN INDICATOR OF POOR SEAL QUALITY. (B)(4).

    Description of Event or Problem · 1

    POSSIBLE PACKAGING INTEGRITY ISSUE WHICH WAS DETECTED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9427 EVA TDC VITRECTOMY PACK VGPC INPUT 25G OPHTHALMIC SURGICAL PROCEDURE PACKS AND KITS QDY D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA

    Patients

    Seq Age Sex Outcome Treatment
    1