BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 21088222 · Received January 6, 2025

    Report

    Report Number
    1911916-2025-00004
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 9, 2024
    Report Date
    January 22, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBER 4213208. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL: 309653 LOT: 4213208. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. INDICATION: NONFAMILIAL HYPOGAMMAGLOBULINEMIA, IMMUNODEFICIENCY, UNSPECIFIED, AND SELECTIVE. DEFICIENCY OF IMMUNOGLOBULIN G[IGG] SUBCLASSES. STRENGTH/DOSE/FREQUENCY: USE AS DIRECTED TO ADMINISTER HIZENTRA (INFUSE 14GM (70ML) SUBCUTANEOUSLY EVERY WEEK). PATIENT REPORTED THAT ON (B)(6) 2024 ONE OF THE 50 ML BECTON DICKINSON SYRINGES HAD A CRACK AND PATIENT LOST HIZENTRA THAT WAS TRANSFERRED. PATIENT LOST MEDICATION FROM 2 OF THE 4 GM SYRINGES AND FROM 1 OF THE 2GM SYRINGES. PATIENT SAID THERE WERE 2 LOT NUMBERS ON THE PACKAGE 4213208 AND 4213235. PATIENT MISSED A DOSE, NO ADVERSE EVENT REPORTED; UNKNOWN IF SYRINGE(S] AVAILABLE FOR RETURN; UNKNOWN IF MD AWARE. REPORTED TO (B)(6) BY PT/CAREGIVER. REF REPORT: MW5163604.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381564 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4213208 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown