BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LL BNS

    MDR report key: 22790054 · Received August 12, 2025

    Report

    Report Number
    1213809-2025-00532
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 23, 2025
    Report Date
    October 2, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). - SUPPLEMENTAL MDR - SILICONE VISIBLE. THE FOLLOWING DEVIATIONS WERE REPORTED DURING THE PACKAGING PROCESS OF 1ML LUER LOK SYRINGES: SILICONE DROPLETS, LOOSE OR MISSING PLUNGERS, PLUNGERS WITHOUT STOPPERS, DAMAGED SYRINGES, MISALIGNED PLUNGERS, DAMAGED TIPS, SCALE MARKING INCONSISTENCIES, EMBEDDED AIR BUBBLES, AND HAZY SYRINGE BARRELS. TO SUPPORT THE INVESTIGATION, (B)(6) SYRINGE SAMPLES WERE SUBMITTED TO THE QUALITY TEAM FOR EVALUATION. ALL SAMPLES WERE RECEIVED FULLY ASSEMBLED AND INDIVIDUALLY PACKAGED IN PLASTIC BAGS. A VISUAL INSPECTION WAS CONDUCTED. THREE SAMPLES EXHIBITED PLUNGER ROD DAMAGE, FIFTEEN WERE MISSING STOPPERS, AND THREE LACKED PLUNGER RODS ENTIRELY. ONE SYRINGE CONTAINED AIR BUBBLES WITHIN THE BARREL, WHILE TWO SHOWED SURFACE SCRAPES. ADDITIONALLY, SIX SYRINGES WERE MISSING PRINTED INFORMATION, TWO HAD DOUBLE PRINTS, TWO EXHIBITED INK SMEARS, AND ONE HAD INK DOTS. THESE CONDITIONS ARE CONSIDERED NON-CONFORMING ACCORDING TO PRODUCT SPECIFICATIONS. THE OBSERVED DEFECTS WERE ATTRIBUTED TO DIFFERENT STAGES OF THE MANUFACTURING PROCESS. PLUNGER ROD DAMAGE, MISSING STOPPERS, MISSING PLUNGER RODS, AND BARREL SCRAPES WERE ASSOCIATED WITH THE ASSEMBLY PROCESS. AIR BUBBLES WITHIN THE BARREL WERE LINKED TO THE MOLDING PROCESS. PRINTING-RELATED ISSUES, INCLUDING MISSING PRINT, DOUBLE PRINT, INK SMEARS, AND INK DOTS, WERE TRACED TO THE MARKING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED FOR MATERIAL NUMBER 309648, LOT 4243174. THE REVIEW CONFIRMED THAT ALL VISUAL INSPECTIONS WERE CONDUCTED IN ACCORDANCE WITH ESTABLISHED REQUIREMENTS. NO QUALITY NOTIFICATIONS WERE RECORDED RELATED TO THE REPORTED CONDITIONS. THE LOT WAS INSPECTED AND ACCEPTED PER THE INSPECTION CONTROL PLAN, APPROVED FOR SHIPMENT, AND DEEMED COMPLIANT WITH PRODUCT SPECIFICATION REQUIREMENTS. 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 1ML LL BNS HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HEREBY SUBMIT OUR FINDINGS AT THE END OF BATCH, AS AGREED UPON. ALL DEVIATIONS WERE FOUND DURING PACKAGING, PRIOR TO STERILIZATION. SO PRIOR TO USE, SO NO MEDICATION AND NO PATIENTS ARE INVOLVED. ARTICLE CODE: 309648, 1ML BULK NS LL BATCH: 4243174 EVENT DATE: 02-05-2025 AND 23-07-2025 STAXS COMPLAINT REF: (B)(4). DEVIATIONS: 55 X SILICON OIL DROPLETS 76 X LOOSE PISTONS (LOOSE PLUNGERS, NO STOPPERS) 56 X DAMAGED SYRINGE 4 X CROOKED PLUNGER 3 X DAMAGED TIP 258 X SCALE MARKING ISSUES 4 X EMBEDDED AIR BUBBLES 3 X HAZY SYRINGES. SAMPLES ARE AVAILABLE AND CAN BE PICKED UP FROM THE FOLLOWING LOCATION: COMPANY: STAXS THE NETHERLANDS BV CITY: (B)(6). COLLECTION POINT:* EXPEDITION COUNTRY: THE NETHERLANDS ADDRESS LINE 1 (STREET, NUMBER): (B)(6),. CONTACT NAME: (B)(6). ADDRESS LINE 2 (BUILDING, FLOOR, N/A PHONE NUMBER: (B)(6).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2401874 BD SYRINGE 1ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4243174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown