BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18 GA APPLICATOR NEEDLE 5

    MDR report key: 11627188 · Received April 7, 2021

    Report

    Report Number
    2020394-2021-00814
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 3, 2021
    Report Date
    September 24, 2021
    Product Code
    IWJ
    UDI-DI
    10801741075961
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE FDA RN NUMBER FOR THE MDR 2020394-2021-00816 WAS INADVERTENTLY SUBMITTED AS 2020394. THE CORRECT FDA RN NUMBER WAS 1018233. H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE BARD BRACHYTHERAPY NEEDLE WAS RETURNED FOR EVALUATION. THE COMPONENTS RECEIVED INCLUDED CANNULAS, STYLETS, WITH NEEDLE PROTECTORS; THE STYLETS WERE RETURNED INSERTED WITHIN THE CANNULAS. THE PACKAGING APPEARED TO BE OPEN AT THE PROXIMAL END. THE DEVICE COMPONENTS APPEARED UNAFFECTED. BASED ON THE FINDINGS, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PACKAGING ISSUE AS THE IT WAS NOTED THAT THE PACKAGING WAS OPENED IN CONDITIONS. A DEFINITIVE ROOT CAUSE FOR THE REPORTED PACKAGING ISSUE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4 (EXPIRY DATE: 02/2023). H11: SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE DEVICE PACKAGE WAS ALLEGEDLY IN OPENED STATE. THERE WAS NO PATIENT CONTACT.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 02/2023). DEVICE PENDING RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE DEVICE PACKAGE WAS ALLEGEDLY OPENED. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524910 18 GA APPLICATOR NEEDLE 5 BRACHYTHERAPY IMPLANT NEEDLES IWJ 918205 REEQ2740 10801741075961

    Patients

    Seq Age Sex Outcome Treatment
    1 Other