BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23788388 · Received December 12, 2025

    Report

    Report Number
    1911916-2025-00791
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    October 14, 2025
    Report Date
    January 8, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT A PARTICLE WAS OBSERVED IN THE PACKAGING OF A 50ML SYRINGE. TO SUPPORT THE INVESTIGATION, ONE SAMPLE WITHOUT BLISTER PACKAGING AND THREE PHOTOGRAPHS WERE SUBMITTED TO THE QUALITY TEAM FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED SAMPLE WAS PERFORMED AT 10X AND 30X MAGNIFICATION. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PLUNGER ROD WAS REMOVED FROM THE SYRINGE BARREL TO ASSESS FOR FOREIGN MATTER; NONE WAS OBSERVED. THE THREE PHOTOGRAPHS DEPICT A SYRINGE WITHOUT PACKAGING AND SHOW A DARK-COLORED SPECK TOWARD THE BOTTOM OF THE SYRINGE. BASED ON THE PHOTOGRAPHS ALONE, IT IS NOT POSSIBLE TO DETERMINE WHETHER THE SPECK IS WITHIN THE SYRINGE BARREL OR ON THE PLUNGER ROD, AND NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE IMAGES. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 309653, LOT 4332228. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH APPLICABLE SPECIFICATIONS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, THE CUSTOMER-REPORTED CONDITION IS SUPPORTED BY THE PHOTOGRAPHIC EVIDENCE BUT WAS NOT CORROBORATED BY THE RETURNED SAMPLE. AS A RESULT, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    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 THE BD SYRINGE 50ML LL TIP 1ML HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SUPPLIER :BD MEDICAL SURGICAL SYSTEMS (B)(6). PRODUCT NAME :50ML SYRINGE, LUER-LOK NO. OF DEFECT UNITS:(B)(4). SUPPLIER BATCH NUMBER: 4332228 DATE OF MANUFACTURING: 01NOV2024 NOVARTIS PURCHASING ORDER: (B)(4). NOVARTIS MATERIAL NO: 2220333 NOVARTIS BATCH NO: S0027 NOVARTIS RECORD NO: (B)(4). DESCRIPTION: ON 14OCT2025, DURING REVIEW A PARTICLE WAS OBSERVED IN PACKAGING OF 50 ML SYRINGE LUER LOCK. SEE PICTURES PROVIDED. DEFECT SAMPLES ARE AVAILABLE AT OUR SITE, PLEASE LET US KNOW IF WE SHOULD RETURN THE AFFECTED UNITS OR IF WE CAN DISPOSE OF THEM ONCE YOUR INVESTIGATION IS COMPLETED. A ROOT CAUSE WITHIN NOVARTIS CAN BE NEARLY BE EXCLUDED. WE KINDLY ASK YOU TO INVESTIGATE THE ROOT CAUSE AND SEND YOUR INVESTIGATION REPORT. IF YOU HAVE ANY FURTHER QUESTIONS, PLEASE DO NOT HESITATE TO CONTACT ME. THANK YOU FOR YOUR SUGGESTIONS FOR FURTHER PROCEEDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2711419 BD LUER-LOK PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 4332228 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown