BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ENTERAL SYRINGE

    MDR report key: 16368756 · Received February 13, 2023

    Report

    Report Number
    1911916-2023-00068
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    October 4, 2022
    Report Date
    July 18, 2024
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2040801. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027. DEVICE MANUFACTURE DATE: 09-FEB-2022. MEDICAL DEVICE LOT #: 2040777. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027. DEVICE MANUFACTURE DATE: 09-FEB-2022. MEDICAL DEVICE LOT #: 2089360. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027. DEVICE MANUFACTURE DATE: 30-MAR-2022. MEDICAL DEVICE LOT #: 2089359. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027. DEVICE MANUFACTURE DATE: 30-MAR-2022. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305864 AND LOT NUMBERS 2040801, 2040777, 2089360, 2089359. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ ENTERAL SYRINGE LEAKED PAST THE PLUNGER/STOPPER WHEN PLACED IN THE PUMP. THIS OCCURRED AT LEAST ONCE EACH IN LOTS 2040801, 2040777, 2089360, AND 2089359. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN LOADING THE SYRINGE, THEY TAKE OUT THE PLUNGER, POUR THE FEEDS INTO THE SYRINGE AND THEN PUT THE PLUNGER BACK ON TO MAINTAIN A CLOSED SYSTEM. THE SYRINGE IS THEN PLACED HORIZONTALLY WITHIN THE PUMP. AT THIS POINT, THE FEEDS ARE LEAKING OUT OF THE TOP END WHERE THE PLUNGER IS PLACED."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654996 BD¿ ENTERAL SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown