BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE PHARMACY CONVENIENCE TRAY, BULK, STERILE

    MDR report key: 17687247 · Received September 5, 2023

    Report

    Report Number
    1911916-2023-00634
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 21, 2023
    Report Date
    October 27, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903056171
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE 1 PHOTO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS NOT CONFIRMED UPON INSPECTION OF THE PHOTO. THE IMAGE PROVIDED ONLY SHOWS THE TOP WEB LABEL OF THE PRODUCT AND THE SAMPLE WAS NOT PRESENT WITHIN THE IMAGE. BD CANNOT CONFIRM THE CAUSE OF THE FAILURES TO OUR MANUFACTURING PROCESS SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE OF THE REPORTED FAILURE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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

    MAT#: 305617, BATCH#: 3150618. IT WAS REPORTED BY THE CUSTOMER THAT A 20MLSYRINGE 305617 FOUND IN A SEALED PACKAGE HAS SLUDGE WITHIN THE SYRINGE. VERBATIM: RCC RECEIVED COMPLAINT VIA EMAIL. CUSTOMER REPORTED: A MEMBER IS REPORTING THAT A 20MLSYRINGE 305617 FOUND IN A SEALED PACKAGE HAS SLUDGE WITHIN THE SYRINGE. WOULD BD RECOMMEND USING THE REMAINDER OF THE SYRINGES IN THE PACKAGE? 16 OCT 2023: MAY I PLEASE CHECK ON THE INFORMATION NEEDED FOR OUR REVIEW? COULD YOU PLEASE PROVIDE OCCURRENCE DATE? 8/21/2023 HOW MANY QUANTITIES OF THE PRODUCT AFFECTED DUE TO THE INCIDENT? 1 SYRINGE IN THE CONVENIENCE PAK IS THERE ANY ADVERSE EVENT ON PATIENT? NO IS SAMPLE AVAILABLE FOR RETURN? IF YES, PLEASE PROVIDE ADDRESS FOR RETURN LABEL. NO, I ONLY HAVE A COPY OF THE PAK LABEL ATTACHED. IS THERE ANY PHOTO OF THE PHOTO OF THE INCIDENT THAT YOU CAN PROVIDE FOR OUR REVIEW? NO, THERE WAS A NEEDLE ATTACHED AND IT WAS PLACED INTO THE SHARPS CONTAINER. NO MEDICATION HAD BEEN DRAWN UP YET, ONLY STERILE WATER WHICH IS HOW THE SLUDGE AT THE PLUNGER WAS DISCOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE PHARMACY CONVENIENCE TRAY, BULK, STERILE HAD FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: A MEMBER IS REPORTING THAT A 20MLSYRINGE 305617 FOUND IN A SEALED PACKAGE HAS SLUDGE WITHIN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155630 BD LUER-LOK¿ SYRINGE PHARMACY CONVENIENCE TRAY, BULK, STERILE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 3150618 30382903056171

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown