BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LL BNS

    MDR report key: 24236297 · Received February 2, 2026

    Report

    Report Number
    1213809-2026-00041
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    September 10, 2025
    Report Date
    March 13, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903096485
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION: A TOTAL OF FIFTY-SIX 1 ML LUER LOK SYRINGES, PART NUMBER 309648, WERE RECEIVED AND EVALUATED. THE SAMPLES ARRIVED LOOSE IN ELEVEN INDIVIDUAL BAGS LABELED WITH BATCH INFORMATION AND NOTED DEFECTS. THIRTY SAMPLES WERE ACCEPTABLE WITH NO DEFECTS OBSERVED, AND THE SILICONE LEVEL AND TIP FLASH WERE WITHIN NORMAL LIMITS. THE REMAINING SAMPLES SHOWED MULTIPLE NONCONFORMANCES, INCLUDING SEVEN WITH MISSING PRINT, FIVE WITH SMEARED PRINT, FIVE WITH PLUNGER ROD DAMAGE, TWO WITH SCUFFED BARRELS, TWO WITH CRUSHED BARRELS, ONE WITH BARREL COLLAR DAMAGE, ONE MISSING A STOPPER, ONE WITH SILVER STREAKS ON THE BARREL, ONE CONTAINING TWO EMBEDDED AIR BUBBLES, AND ONE WITH BLACK DISCOLORATION ON THE PLUNGER CAUSED BY A BURNT PLUNGER ROD. THESE DEFECTS DO NOT MEET PRODUCT SPECIFICATIONS. THE LIKELY ROOT CAUSES FOR FOREIGN MATTER IN THE PLUNGER ROD, AIR BUBBLES, AND SILVER STREAKS ARE RELATED TO THE MOLDING PROCESS, WHERE MOISTURE OR DEGRADED PLASTIC CAN BECOME EMBEDDED DURING PRODUCTION. DEGRADED PLASTIC TYPICALLY RESULTS FROM RESIN BEING EXPOSED TO HIGH TEMPERATURES FOR EXTENDED PERIODS DURING START UP, AND IF START UP SCRAP IS NOT FULLY PURGED, AFFECTED PARTS MAY PASS THROUGH. THIS CONDITION IS COSMETIC AND DOES NOT POSE A RISK TO CUSTOMERS. PRINT RELATED ISSUES ARE LIKELY DUE TO THE MARKING PROCESS, WHILE BARREL DAMAGE, PLUNGER ROD DAMAGE, AND MISSING STOPPERS ARE LIKELY ASSOCIATED WITH THE ASSEMBLY PROCESS. THE REPORTED ISSUES OF VISIBLE SILICONE AND EXCESSIVE BARREL TIP FLASH WERE NOT OBSERVED IN THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309648, LOTS 5031826 AND 5127767. ALL IN PROCESS AND FINAL VISUAL INSPECTIONS WERE PERFORMED AS REQUIRED, AND NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE LOTS MET ACCEPTANCE CRITERIA PER THE INSPECTION CONTROL PLAN, WERE APPROVED FOR SHIPMENT, AND WERE FOUND TO BE IN COMPLIANCE WITH APPLICABLE PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 1ML LL BNS CONTAINED FOREIGN MATTER. IT WAS REPORTED THE PACKAGING 1ML¿S AND WE HEREBY SUBMIT THE DEVIATIONS FOUND. ALL DEVIATIONS WERE FOUND DURING PACKAGING, PRIOR TO USE, SO NO PATIENTS WERE INVOLVED. EVENT DATE: 10/09/2025 AND 14/01/2026. STAXS COMPLAINT REF: (B)(4). ARTICLE CODE: 309648, 1 ML LL NS BULK. WE PRODUCED 2 BATCHES AND USED TWO BD BATCHES: 1ST BATCH SOLELY 5031826 AND 2ND BATCH 5031826 AND 5127767: BATCH 1: 5031826. 44 X SCALE MARKING ISSUES, 76 X CROOKED PLUNGER, 6 X DAMAGED SYRINGE, 1 X BLACK PLUNGER. BATCH 2: 5031826 (9 CASES) AND 5127767 31 CASES. 63 X SYRINGES WITH LARGE SILICON DROPLET AT THE STOPPER. 70 X PLASTIC FLASH ON THE TIP. TIP OPENING IS NOT ROUND ANYMORE. WE SEE THIS WITH OTHER SYRINGE SIZES AS WELL. DID SOMETHING CHANGE IN THE PRODUCTION PROCESS? 35 X SCALE MARKING ISSUE, 115 X CROOKED PLUNGER, 10 X DAMAGED SYRINGE, 1 SYRINGE WITH AIR BUBBLES IN THE PISTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594994 BD SYRINGE 1ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5031826 50382903096485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other