BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITAS ADVANCED INFUSION PACK

    MDR report key: 17073848 · Received June 6, 2023

    Report

    Report Number
    3012236936-2023-01416
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 12, 2023
    Report Date
    August 15, 2023
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    35050474700902
    PMA / PMN Number
    K203060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: RETURNED TO MANUFACTURER ON: JULY 7, 2023. SECTION H3: DEVICE EVALUATED BY MANUFACTURER¿ YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED OPEN WITHIN ORIGINAL PACKAGING, CONFIRMING THE REPORTED LOT NUMBER. A VISUAL INSPECTION OF THE RETURNED PRODUCT DID NOT REVEAL ANY OBVIOUS DEFECTS OR DAMAGE. NO WELD GAP PROTRUSION WAS OBSERVED. FUNCTIONALITY TEST WERE PERFORMED, AND THE RESULTS WERE FOUND WITHIN SPECIFICATIONS. THE REPORTED EVENT CANNOT BE CONFIRMED. BASED ON THE INFORMATION OBTAINED, THERE IS NO INDICATION OF PRODUCT MALFUNCTION OR PRODUCT DEFICIENCY. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS PER GLOBAL COMPLAINT TRENDING ((B)(6)). THERE WAS NO RELATED DEVIATION, NCMR, NC OR CAPA INITIATED DURING THE MANUFACTURING PROCESS OF THE REPORTED LOT. ALL DEVICES MEET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE INFORMATION: SECTION E1: TELEPHONE NUMBER: (B)(6). H-81. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERROR 161 (GAS FORCED INFUSION PRESSURE IS TOO HIGH) OCCURRED DURING ULTRASOUND IN CATARACT SURGERY. AFTER THAT, CUSTOMER USED IRRIGATION ASPIRATION, AND IT FAILED TO ASPIRATE. THE PACK WAS RELOADED; HOWEVER, THE ISSUE WAS NOT RESOLVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER VRT-AI PACK. THERE WAS NO PATIENT INJURY. THE PRODUCT WILL BE RETURNED. THE PACK WAS NOT REUSED. REPORTEDLY INSTRUCTION FOR USE WAS PROPERLY FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093719 VERITAS ADVANCED INFUSION PACK UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. VRT-AI 60416304 35050474700902

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown