BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 25004830 · Received April 27, 2026

    Report

    Report Number
    1213809-2026-00221
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 26, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 1ML LL CONTAINED FOREIGN MATTER. WE WOULD LIKE TO FILE A PRODUCT COMPLAINT FOR DULL 1 ML SYRINGES. DATE OF THE EVENT: 04/03/2026 HOW MANY ITEMS WERE AFFECTED PER LOT? 1 IS THE PRODUCT AVAILABLE TO BE RETURNED FOR INVESTIGATION? NO, CONTROLLED SUBSTANCE. HOW MANY ITEMS ARE AVAILABLE TO RETURN? 0. OUR INTEGRADOSE REFERENCE NUMBER IS: (B)(4). ON 04/03/2026, DURING PRODUCTION USING THE 1ML SYRINGES, PN 309701, TECHNICIANS OBSERVED A PARTICLE INSIDE FINAL PRODUCT SYRINGES DURING VISUAL INSPECTION. THE SYRINGES WERE FROM LOT # 6037799. THESE SYRINGES ARE USED BY INTEGRADOSE FOR DELIVERY OF THE CONTROLLED SUBSTANCE HYDROMORPHONE, SO WE ARE UNABLE TO PROVIDE THESE SYRINGES TO YOU. PLEASE SEE THE ATTACHED PICTURE OF THE PARTICLE. STAFF HAS IDENTIFIED THIS PARTICLE AS ¿A PIECE OF CARDBOARD, IS IN SOLUTION NOT EMBEDDED IN PLASTIC.¿ PARTICLES IN THESE SYRINGES ARE NEW TO INTEGRADOSE. THE LOTS USED IN PRODUCTION INCLUDE THE FOLLOWING. LOT # 6037799 EXP # 2031-01-31 USED IN PRODUCTION 990 PREVIOUSLY FILED. THE MEDICATION IN FLUID AT THE TIME OF THE EVENT WAS HYDROMORPHONE HCL THERE WAS NO DELAY OF OR CHANGE IN THE COURSE OF TREATMENT AS THIS SYRINGE HAD NOT BEEN SPECIFICALLY PRESCRIBED TO A PATIENT AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378042 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 6037799 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1