BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER

    MDR report key: 17152841 · Received June 19, 2023

    Report

    Report Number
    3003916417-2023-00131
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    May 24, 2023
    Report Date
    January 23, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FOZ
    UDI-DI
    30382903811237
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE ORIGINALLY PROVIDED FEEDBACK, THIS RECORD WAS OPENED FOR A DEFECTIVE CATHETER PRODUCT FOUND WITHIN A SHELF CARTON. THE SAMPLE RETURNED WAS AN INDIVIDUAL INSYTE AUTOGUARD PRODUCT (MATERIAL (B)(4) AND LOT 2318743) WHICH DIFFERED FROM THE RETURNED SHELF CARTON FOR ANGIOCATH PRODUCT (MATERIAL (B)(4) AND LOT 1110980). UPON THE ADDITIONAL FEEDBACK PROVIDED, THE REPORT THAT THE AFFECTED INSYTE AUTOGUARD PRODUCT WAS FOUND WITHIN THE ANGIOCATH SHELF CARTON, A SECONDARY INVESTIGATION WAS PERFORMED FOR THE POTENTIAL ISSUE OF MIXED PRODUCT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR ORIGINALLY PROVIDED MATERIAL NUMBER (B)(4)AND LOT NUMBER 1110980. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION OR PACKAGING PROCESSES THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. MATERIAL (B)(4) AND LOT 2318743 ARE NOT PACKAGED AT THE SAME FACILITY WHICH MANUFACTURES AND PACKAGES MATERIAL (B)(4) AND LOT 1110980. ANGIOCATH LOT 1110980 WAS MANUFACTURED AT BD JUIZ DE FOR A (BRAZIL) IN APRIL 2021. INSYTE AUTOGAURD LOT 2318743 WAS MANUFACTURED AT BD SANDY (UTAH, USA) IN NOVEMBER 2022. NO MIXTURE OF PRODUCT COULD HAVE OCCURRED AT THE BD JUIZ DE FORA LOCATION. IT HAS ALSO BEEN DETERMINED THAT NO MIXING COULD HAVE OCCURRED AT THE BD DISTRIBUTION CENTER AS THESE PRODUCTS DO NOT PASS THROUGH THE SAME BRAZILIAN DISTRIBUTION CENTER TO ALLOW THIS POSSIBILITY. AT THIS TIME, NO MANUFACTURING OR BD RELATED PROCESS COULD BE DETERMINED FOR THIS REPORTED MIXED PRODUCT ISSUE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER WAS FOUND BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV CATHETER FOUND BROKEN IN BOX; NO OTHER CATHETERS SEEMED TO BE IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102405 BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON IND. CIRURGICAS LTDA 381123 1110980 30382903811237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown