BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23480455 · Received November 5, 2025

    Report

    Report Number
    1911916-2025-00720
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 10, 2025
    Report Date
    October 23, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028306
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REPORT WAS RECEIVED INDICATING THAT THE PLASTIC ENVELOPE OF A SYRINGE WAS WRAPPED WITH BLACK TAPE AROUND THE SYRINGE BAG. TO SUPPORT THE INVESTIGATION, TWO PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. THE IMAGES DEPICT A SET OF PACKAGING BLISTERS WITH DARK-COLORED TAPE APPLIED TO THE TOP WEB OF THE PACKAGING. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE OBSERVED. THE DARK TAPE IS TYPICALLY USED AS A SPLICE WHEN INTRODUCING A NEW ROLL OF PACKAGING TOP WEB; HOWEVER, IN THIS INSTANCE, THE AFFECTED UNITS SHOULD HAVE BEEN REMOVED AND DISCARDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR MATERIAL NUMBER 302830, LOT 5183343. THE ASSESSMENT DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. THE SUBMITTED PHOTOGRAPHS WILL BE SHARED WITH PRODUCTION ASSOCIATES TO RAISE AWARENESS. TO DATE, NO SIMILAR INCIDENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE PHOTOGRAPHIC EVIDENCE, THE CUSTOMER-REPORTED CONDITION HAS BEEN CONFIRMED. 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 SYRINGE 20ML LL S/C 48 PACKAGE WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 302830 BATCH # 5183343. CUSTOMER SENT AN EMAIL ASKING IF IT IS NORMAL THAT THEY RECEIVED SYRINGES 302830 WHEREBY THE PLASTIC ENVELOP HAS A BLACK TAPE AROUND THE SYRINGE BAG. PLEASE NOTE THAT THE HOSPITAL USES CARDINAL JUST IN TIME FOR DELIVERY OF MATERIALS TO THEIR HOSPITAL. HERE ARE THE QUESTIONS I ASKED THE CUSTOMER: BD:DID YOU RECEIVE A FULL BOX WITH THIS TAPE ON THE ENVELOPES? WAS THE CASE SEALED? ANSWER: EVERYTHING IS UNPACKED IN STERILE AREAS. OUR STAFF DOES NOT APPLY ADHESIVE TAPE TO MEDICAL SUPPLIES. BD:WAS THIS ORDER A SAMPLE REQUEST? ANSWER: NO, REGULAR ORDER. BD: OUR SYRINGE PACKAGING WOULD NOT COME LIKE THAT IN THE BOX, BUT IF THE BOX HAD BEEN OPENED, PERHAPS THE DISTRIBUTOR OR OUR SAMPLE ROOM APPLIED THE TAPE. ANSWER: OUR DISTRIBUTOR IS HEALTH. THE PRODUCT IS STORED AT THE HEALTH DISTRIBUTION CENTER. BD: I TRIED TO REACH YOU BY PHONE. I LEFT YOU A MESSAGE. I¿M GOING TO OPEN A PRODUCT COMPLAINT. HOWEVER, IF I UNDERSTAND CORRECTLY, DELIVERS THE PRODUCTS TO YOU WITHOUT CARDBOARD BOXES. SO, IS IT RELEVANT TO CHECK WITH THEM WHETHER THEY APPLY TAPE TO THE ENVELOPES?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491772 BD LUER-LOK PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5183343 00382903028306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown