BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 30ML LL S/C 56

    MDR report key: 23198632 · Received October 2, 2025

    Report

    Report Number
    1911916-2025-00664
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 9, 2025
    Report Date
    September 22, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REPORT WAS RECEIVED INDICATING THE PRESENCE OF BLACK PARTICLES IN SYRINGES. TO SUPPORT THE INVESTIGATION, THREE SEALED BLISTER-PACKAGED SAMPLES AND TWO PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION WAS CONDUCTED USING 10X AND 30X MAGNIFICATION. NO DEFECTS, IMPERFECTIONS, OR FOREIGN MATERIAL WERE OBSERVED IN THE RETURNED SAMPLES. THE SUBMITTED PHOTOGRAPHS DEPICTED A SYRINGE WITH DARK DISCOLORATION OUTSIDE OF ITS BLISTER PACKAGING. HOWEVER, THE NATURE OF THE DISCOLORATION COULD NOT BE DETERMINED FROM THE IMAGES ALONE, AND NO ADDITIONAL INFORMATION COULD BE EXTRACTED FROM THE PHOTOGRAPHS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER: 302832, LOT: 5091289. THE REVIEW FOUND NO QUALITY ISSUES DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO ASSOCIATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION, INCLUDING THE ANALYSIS OF THE RETURNED SAMPLES, THE REPORTED ISSUE COULD NOT BE CONFIRMED. WHILE THE PHOTOGRAPHS DO SHOW DISCOLORATION, THE ABSENCE OF A DEFECTIVE PHYSICAL SAMPLE FOR FURTHER ANALYSIS PREVENTS IDENTIFICATION OF A PROBABLE ROOT CAUSE. 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 30ML LL S/C 56 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 302832, BATCH#: 5091289. RCC RECEIVED A COMPLAINT VIA EMAIL. O&M COMPLAINT RECORD NUMBER(S): (B)(4). O&M PRODUCT NUMBER: 0723302832. SUPPLIER PRODUCT NUMBER: 302832. SUPPLIER PRODUCT DESCRIPTION: BD SYRINGE ONLY 30ML LUER. SUPPLIER LOT NUMBER(S): 5091289. QUANTITY INVOLVED: 2 CS. SAMPLE AVAILABLE: Y. IS INVESTIGATION RESPONSE REQUESTED: N. CUSTOMER REIMBURSEMENT REQUEST IS AS FOLLOWS: DC#: 53. O&M PO#: (B)(4). CREDIT OR REPLACEMENT REQUEST: CREDIT/REPLACEMENT. THE DETAILS OF THE REPORTED COMPLAINT: (B)(4). DATE OF EVENT: 9/9/2025. BLACK PARTICLES FOUND INSIDE SYRINGES - EMBEDDED FOREIGN MATTER. HB. WE WERE IN IV ROOM COMPOUNDING SMOF LIPIDS, SINCE THOSE ARE WHITE, WE COULD SEE THE BLACK PARTICLES EASILY. WAS PATIENT OR END-USER INJURED: N. WHEN WAS INCIDENT NOTICED: DURING USE. WAS INCIDENT DISCOVERED DURING DIRECT PATIENT CARE: Y. WAS ANY MEDICAL TREATMENT REQUIRED: N. DID CUSTOMER FILE A REPORT WITH XX AUTHORITY(IES): N.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2622304 BD SYRINGE 30ML LL S/C 56 PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5091289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown