BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE NON STERILE 50ML LL

    MDR report key: 22292232 · Received June 19, 2025

    Report

    Report Number
    3003152976-2025-00293
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    June 10, 2025
    Report Date
    September 12, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903002233
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION MULTIPLE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE SAMPLES WERE RECEIVED IN FIVE SEPARATE BAGS, EACH CATEGORIZED BY DEFECT TYPE. GIVEN THE SAMPLES ARRIVED WITHOUT THEIR PACKAGING, WE CANNOT IDENTIFY WHICH SYRINGE CORRESPONDS TO EACH LOT. THE FOLLOWING OUTLINES OUR OBSERVATIONS: 1. BROKEN PISTON: FINDINGS: FOUR SYRINGES WERE FOUND WITH DAMAGE TO THE PLUNGER ROD. THREE HAD BROKEN AND BENT HEADS, WHILE ONE HAD A BROKEN ROD BODY. ROOT CAUSE: THE DAMAGE IS LIKELY DUE TO PRODUCT JAMMING WITHIN THE MANUFACTURING EQUIPMENT 2. DAMAGED LUER LOCK: FINDINGS: THREE SYRINGES SHOWED ISSUES WITH THE LUER LOCK AREA. TWO HAD VISIBLE CONNECTOR DAMAGE, AND ONE HAD A BURR OBSTRUCTING THE CONE TIP AND WAS MISSING ITS PLUNGER. ROOT CAUSE: 3. LOOSE STOPPER (GUM): FINDINGS: TWO SYRINGES HAD STOPPERS THAT WERE JAMMED AND UNABLE TO MOVE FREELY. ROOT CAUSE: LIKELY CAUSED BY MISALIGNMENT DURING THE ASSEMBLY PROCESS, RESULTING IN INCORRECT POSITIONING AND MISALIGNMENT OF THE STOPPER WITH THE BARREL. 4. PARTICLES: FINDINGS: THREE SYRINGES CONTAINED VISIBLE PARTICLES AT THE BASE OF THE STOPPER. CHARACTERIZATION TESTING WAS PERFORMED AND IDENTIFIED THE PARTICLES WERE CONSISTENT WITH POLYPROPYLENE AND FRAGMENTS OF THE CONVEYOR BELT. ROOT CAUSE: THE LARGEST PARTICLE MAY HAVE DETACHED FROM A CONVEYOR BELT AND ENTERED THE BARREL. THE POLYPROPYLENE PARTICLES CAN GENERATED DUE TO FRICTION BETWEEN THE SYRINGE AND SURFACES ALONG THE ASSEMBLY LINE. AREAS ARE PROTECTED TO REDUCE PARTICLE GENERATION. 5. INK, BURNS, AND STAINS: FINDINGS: SIX SYRINGES WERE AFFECTED: FOUR HAD MINOR INK STAINS. TWO CONTAINED EMBEDDED BLACK PARTICLES¿ONE IN THE STOPPER HEAD AND ONE AT THE BARREL BASE. ROOT CAUSE: INK STAINS MAY RESULT FROM A DAMAGED SCALE MARKING PAD OR INADEQUATE DRYING, PREVENTING PROPER INK ADHESION. THE EMBEDDED PARTICLES ARE LIKELY DUE TO CONTAMINATION DURING THE MOLDING PROCESS, POSSIBLY FROM RESIDUAL DIRT IN THE MOLD OR INSUFFICIENT PURGING DURING INJECTOR STARTUP A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 2406025, 2405036, 2403041,2404022 AND 2408004. ONE ANNOTATION WAS FOUND WITHIN DEVICE RECORDS FOR LOT 2403032 THAT IS RELATED TO A BROKEN PLUNGER. NO DEVIATIONS OR NON-CONFORMANCES RELATED TO ANY OF THE OTHER OBSERVATIONS WERE IDENTIFIED. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. MANUFACTURING EQUIPMENT IS PROTECTED TO AVOID PARTICLES FROM GENERATING DURING MOVEMENT OF THE PIECES WITHIN THE MACHINES. WE PERFORM INSPECTIONS AND CLEARLY DEFINED CLEANING PROCEDURES. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. NO ISSUES RELATED TO THE REPORTED OBSERVATION WERE FOUND. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THESE OBSERVATIONS TO INCREASE AWARENESS DURING OUR INSPECTIONS.

    Description of Event or Problem · 0

    DESCRIPTION: - PRESENCE OF PARTICLES; PARTICLES ARE LOCATED WITHIN THE FLUID PATH. EVENT DETAILS: DURING THE PROCESSING OF PRODUCT CODES 302055 (20 ML SYRINGE) ¿ 300223 (50 ML SYRINGE), OPERATORS DISCARDED MANY UNITS FOR A VARIETY OF REASONS. BELOW THE MAIN DEFECTS FOUND: - PRESENCE OF PARTICLES. - BROKEN PISTON HEAD. - PRESENCE OF INK BURNS/STAINS. - DAMAGED LUER LOCK. - CROOKED LUER LOCK. - SCRATCHES ON SCREEN PRINTING. - LOOSE GUM. PER CUSTOMER RESPONSE (B)(6) 2025: 1. IS IT POSSIBLE TO CHECK THE SPECIFIC PROBLEM WITH EACH BATCH SUPPLIED? YES, THE SAME PROBLEMS ARE RECURRING ON ALL BATCHES OF 50 ML SYRINGES (CODE 300223). 2. HAVE THESE PROBLEMS BEEN IDENTIFIED BEFORE USE? YES, IT IS PRODUCTION WASTE. 3. CAN YOU CONFIRM WHETHER THE OBSERVED PARTICLES ARE INSIDE THE FLUID PATH, OUTSIDE THE DEVICE, OR INSIDE THE PRODUCT PACKAGING? PARTICLES ARE LOCATED WITHIN THE FLUID PATH. 4. IS IT POSSIBLE TO OBTAIN MORE INFORMATION ABOUT "LOOSE RUBBER"? IS THERE A SUBSTANCE IN THE PRODUCT? IS THERE A DETACHED COMPONENT? PLEASE DESCRIBE. THE BLACK RUBBER IS MELTED/MELTED. 5. DOES "BROKEN PISTON HEAD" MEAN THE PART OF THE PISTON THAT IS PRESSED WITH THE THUMB? YES, EXACTLY. 6. CAN YOU SPECIFY WHICH FAULT IS ASSOCIATED WITH SPECIFIC BATCHES? THE SAME PROBLEMS ARE RECURRING ON ALL BATCHES OF 50 ML SYRINGES (CODE 300223). THE DEFECTS FOUND ON THE 20 ML SYRINGES ARE MAINLY: PRESENCE OF PARTICLES/FOREIGN BODIES AND FADED/NON-HOMOGENEOUS SCREEN PRINTING IN ALL POINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853744 SYRINGE NON STERILE 50ML LL SYRINGE, PISTON FMF BECTON DICKINSON UNKNOWN 50382903002233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown