BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS / BIOFLO

    MDR report key: 7591595 · Received June 12, 2018

    Report

    Report Number
    1317056-2018-00104
    Event Type
    Injury
    Date Received
    June 12, 2018
    Report Date
    September 21, 2018
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJS
    UDI-DI
    H965458950
    PMA / PMN Number
    K133264
    Removal / Correction Number
    Z-2196-2018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED PACKAGING LOT (5304321) FOR ITEM NUMBER H965458950 HAD PURCHASED COMPONENT ITEM NUMBER 06509208 (ANGIODYNAMICS LOT 640497 [SL#: (B)(4)]) PACKAGED IN IT. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THERE HAVE BEEN NO PREVIOUSLY REPORTED COMPLAINTS FOR PACKAGING LOT 5304321 OR PURCHASED INTRODUCER COMPONENT LOT {640497} FOR SIMILAR ISSUES. THE RECENT ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE BIOFLO PICC PRODUCT FAMILY AND THE FAILURE MODE "PATIENT INJURY - INFECTION." NO ADVERSE TRENDS WERE INDICATED. THE END USER HOSPITAL'S REPORTED COMPLAINT DESCRIPTION CANNOT BE CONFIRMED GIVEN THE NATURE OF THE ADVERSE EVENT. THE CUSTOMER WAS REVIEWING PATIENT'S AFFECTED BY THE GALT SHEATH RECALL AND OBSERVED INFECTION POST PLACEMENT. ANGIODYNAMICS RECEIVED BIO-TESTING RESULTS OF GALT MANUFACTURING PROCESS PERFORMED BY NELSON LABS. ONLY ONE ORGANISM PRESENT HAS POTENTIAL TO PRODUCE ENDOTOXIN REACTION. THE RELATIONSHIP BETWEEN THE GALT SHEATH AND THE PATIENT INFECTION CANNOT BE DEFINITIVELY DETERMINED BY ANGIODYNAMICS. GALT MEDICAL HAS INITIATED A CAPA TO ADDRESS THE ISSUE REGARDING RECALL # Z-2196-2018. (PR (B)(4)).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS EVENT IS ONGOING, BOTH AT ANGIODYNAMICS AND AT (B)(4). UPON COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. ((B)(4)).

    Description of Event or Problem · 1

    ANGIODYNAMICS WAS NOTIFIED BY (B)(4), THE SUPPLIER OF INTRODUCER SHEATHS, THAT THEY HAVE INITIATED A RECALL (1649395-05-02-2018-001-R) ON SPECIFIC DEVICE LOTS DUE TO "UNSAFE LEVELS OF BACTERIAL ENDOTOXINS (PYROGENS) THAT WERE INTRODUCED DURING A MANUFACTURING STEP." (B)(4) HAS INFORMED ANGIODYNAMICS THAT USE OF THE INTRODUCERS MAY EXPOSE PATIENTS/END USERS TO "BACTERIAL ENDOTOXINS, ALSO CALLED PYROGENIC BACTERIA THAT CAN ACTIVATE THE INFLAMMATORY PROCESS AND PRODUCE FEVER, CHILLS, AND HYPOTENSION IN A PATIENT." AS A RESULT OF THE (B)(4) RECALL, ANGIODYNAMICS IS CONDUCTING A VOLUNTARY RECALL (REMOVAL) OF THE AFFECTED ANGIODYNAMICS PRODUCTS. THE RECALL NOTIFICATION LETTERS WERE DELIVERED TO AFFECTED CONSIGNEES ON FRIDAY MAY 11, 2018. AFTER RECEIVING NOTIFICATION, THE END USER HOSPITAL HAS REPORTED: "PATIENT EXHIBITED POTENTIAL INFECTIOUS SYMPTOMS THE DAY AFTER PROCEDURE UTILIZING A BIOFLO PICC. INCREASED TEMP AND HR OVER THE FOLLOWING 24 HOURS TO 38.5 (101.3) DESPITE ANTIBIOTICS. BLOOD CULTURES, CHEST X-RAY ID CONSULT ON (B)(6). NO TREATMENT REQUIRED. NO ADDITIONAL MEDICATIONS INITIATED - HAD BEEN ON MORPHINE Q4 IV AND OXYCODONE 4-6 HOURS FOR SEVERAL DAYS. NO CHANGE IN FREQUENCY OF THESE MEDICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434710 ANGIODYNAMICS / BIOFLO PERIPHERALLY INSERTED CENTRAL CATHETER LJS ANGIODYNAMICS 5304321 H965458950

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention