BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVID MEDICAL

    MDR report key: 9483644 · Received December 17, 2019

    Report

    Report Number
    1047429-2019-00020
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    August 22, 2019
    Report Date
    December 17, 2019
    Manufacturer
    AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION OPENED; HOWEVER, LIMITED INVESTIGATION DUE TO LACK OF APPLICABLE LOT NUMBER OR SAMPLE. NO SIMILAR COMPLAINTS HAVE BEEN REPORTS FOR ANY KITS. STERILIZATION RECORDS FIND NO FAILURES. ADDITIONALLY THE END-USER INDICATES OTHER KITS MANUFACTURED BY ALTERNATE SUPPLIERS WERE USED IN PROCEDURE AS WELL AS POSSIBLE CONTRIBUTERS.

    Description of Event or Problem · 1

    AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY (REF: 140-01 BAL CATH PREP PK W/SPEC TRAP). AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2019 ORIGINATED BY (B)(4), TECHNICAL QUALITY LEADER AT (B)(6) STATING THAT THEY RECEIVED A SINGLE REPORT FROM THEIR CUSTOMER, (B)(6), OF SEVEN INSTANCES OF PATIENT INFECTION FOLLOWING THE USE OF THE AVID MEDICAL ITEM NO. 140-01 BAL CATH PREP PK W/SPEC TRAP. THE DEVICE HOWEVER WAS USED IN CONJUNCTION WITH A SECOND MEDICAL CONVENIENCE KIT, WHICH IS NOT MANUFACTURED BY AVID MEDICAL. IT WAS REPORTED BY (B)(6) THAT EACH PATIENT DEVELOPED THE SAME TYPE OF INFECTION FOLLOWING THE PROCEDURES. THE COMPLAINT LOT NUMBERS WERE NOT PROVIDED BY THE HOSPITAL AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) FOR THE REPORTED EVENTS. (B)(6) SUBMITTED THE FOLLOWING MDRS FOR THE SEVEN EVENTS: 3011270181-2019-00032, 3011270181-2019-00033, 3011270181-2019-00034, 3011270181-2019-00035, 3011270181-2019-00036, 3011270181-2019-00037 AND 3011270181-2019-00038. THERE HAVE BEEN NO STERILE LOAD FAILURES AT AVID MEDICAL. EACH BATCH OF THIS PRODUCT CODE MET A STERILITY ASSURANCE LEVEL OF 10-6 ON ALL LOADS MANUFACTURED N THE LAST 3 YEARS, WITH NO BIOLOGICAL INDICATOR FAILURES. ONE ITEM, VIAL,SODIUM CHLORIDE. 9,50ML (NDC 0409-4888-50), IS PROVIDED AS A PIGGYBACKED ITEM (PACKAGED EXTERNALLY NOT SUBJECT TO STERILIZATION BY AVID MEDICAL) FOR THIS MEDICAL CONVENIENCE KIT. THIS SODIUM CHLORIDE PRODUCT WAS REPORTED TO PFIZER INC VIA PHONE BY AVID'S COMPLAINT TEAM ON (B)(6) 2019. AT THIS TIME THERE HAS BEEN NO RESPONSE FROM PFIZER TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272926 AVID MEDICAL BAL CATH PREP PK W/SPEC TRAP LRO AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 140-10 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other