BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18882071 · Received March 11, 2024

    Report

    Report Number
    1213809-2024-00157
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    February 16, 2024
    Report Date
    July 25, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ONE PHOTO SHOWS THE TOP WEB SLIP OF THE PACKAGE WITH THE APPLICABLE PRODUCT INFORMATION, AND OTHER PHOTO SHOWS A LOOSE SYRINGE WITH THE STOPPER INSECURE TO THE PLUNGER. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE STOPPER INSECURE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THIS DEFECT IS OCCURRING BELOW AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3150949. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK STOPPER WAS JAMMED/INSECURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "3 ML SYRINGE WAS DEFECTIVE WHILE DRAWING UP MEDICATION FOR SICK NEWBORN (PLUNGER FAILURE).¿ EVENT DATE: 2-16-2024 EVENT LOCATION: (B)(6) HOSPITAL, (B)(6). EVENT DESCRIPTION: ¿3 ML SYRINGE WAS DEFECTIVE WHILE DRAWING UP MEDICATION FOR SICK NEWBORN (PLUNGER FAILURE).¿ HARM TO TEAM MEMBER OR PATIENT? NO PRODUCT NAME: ITM-1120081 - SYRINGE 3ML LUER LOC TIP PRODUCT REF: 309657 LOT NUMBER: 3150949 BD CUSTOMER ACCOUNT NUMBER: (B)(4). PHOTOS OF SYRINGE AND PACKAGING ARE ATTACHED. ADDITIONAL INFORMATION PROVIDED ON 02/28/2024: WHEN DID THE INCIDENT OCCUR? ON (B)(6) 2024 ANY PHYSICAL SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO PHYSICAL SAMPLE IS AVAILABLE; PHOTOS ARE ATTACHED TO THIS EMAIL. CAN YOU PLEASE PROVIDE MORE DETAILS AND DESCRIBE HOW THE PRODUCT IS DAMAGED. IT APPEARS THAT THE SEAL FOR THE PLUNGER BECAME LODGED IN THE SYRINGE UPON USE. WAS THE PRODUCT DAMAGED AS WELL? NO INITIAL DAMAGE WAS NOTED WHEN UNPACKAGED. WAS THE STERILITY BREACHED DUE TO THE DAMAGE? UNKNOWN HOW WAS TREATMENT COMPLETED FOR CUSTOMER? NEW SYRINGE WAS OBTAINED AND USED. PLEASE CONFIRM WHETHER THERE WAS ANY PATIENT IMPACT. NO PATIENT IMPACT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2455843 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3150949 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown