BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 21780884 · Received April 4, 2025

    Report

    Report Number
    1213809-2025-00243
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 13, 2025
    Report Date
    April 11, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. 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). SUPPLEMENTAL MDR - FOREIGN MATTER. TWELVE SAMPLES AND NINE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL SAMPLES WERE RECEIVED LOOSE IN SEVEN DIFFERENT BAGS. SIX BAGS WERE FROM BATCH 4214768. ONE BAG CONTAINED ONE SYRINGE, AND THE OTHER FIVE BAGS CONTAINED TWO SYRINGES EACH. ONE BAG WITH ONE SYRINGE IS LABELED AS WHITE PARTICULATE WITH NO DEFECTS OBSERVED. THE SECOND BAG LABELED AS DISCOLORED RESIDUE IN BARREL HAS SILICONE VISIBLE ON THE STOPPER. HOWEVER, IT IS NOT EXCESSIVE AND IS THEREFORE ACCEPTABLE. THE THIRD BAG LABELED AS WHITE RESIDUE IN BARREL HAS ONE SYRINGE WITH NO DEFECTS OBSERVED AND ANOTHER SYRINGE HAS ONE UNKNOWN WHITE PARTICULATE OBSERVED ON THE STOPPER. THE FOURTH BAG LABELED AS TAN PARTICULATE HAS ONE SYRINGE WITH NO DEFECTS OBSERVED AND THE OTHER SYRINGE HAS SCRATCH ON THE BARREL. THE FIFTH BAG LABELED AS WHITE PARTICULATE HAS ONE SYRINGE WITH NO DEFECTS OBSERVED AND THE OTHER SYRINGE HAS UNKNOWN WHITE PARTICULATE ON THE SIDE OF THE STOPPER OUT OF THE FLUID PATH. THE LAST BAG LABELED AS BLACK PARTICULATE HAS ONE BLACK DOT ON THE ROOF OF EACH OF THE BARRELS CONSISTENT WITH EMBEDDED FOREIGN MATTER. ONE BAG WAS RECEIVED FROM BATCH 4122257. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS WERE OBSERVED. THE NINE PHOTOS ARE EXTREME CLOSE-UP IMAGES. THREE PHOTOS SHOW THE STOPPER WITH A DARKER BLACK AT THE OUTER EDGE. THIS CONSISTENT WITH SILICONE BUILDUP. THREE PHOTOS FOCUS ON THE ROOF OF THE BARREL WITH NO DEFECTS OBSERVED. THE SEVENTH PHOTO SHOWS TWO UNKNOWN WHITE DOTS NEAR THE EDGE OF THE STOPPER. THE EIGHTH PHOTO SHOWS MULTIPLE CIRCLES IN THE TIP OF THE BARREL CONSISTENT WITH FLUID HAVING BEEN INSIDE THE BARREL; THIS CANNOT BE CONFIRMED TO HAVE ORIGINATED AT THE MANUFACTURING PLANT. THE LAST PHOTO SHOWS UNKNOWN WHITE CIRCLE CONSISTENT WITH EMBEDDED BUBBLES IN THE BARREL. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS PERFORMED ON ALL PARTICULATE AND WAS CONFIRMED TO BE THE SILICONE USED IN THE MANUFACTURING PROCESS. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. THE ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER AND BUBBLE DEFECTS ARE ASSOCIATED WITH THE MOLDING PROCESS. IF A SMALL AMOUNT OF WATER PARTICLES MAKES IT INTO THE MOLD, THEY BECOME VAPORIZED AND CAN CREATE AN EMBEDDED CONCENTRATION OF THIS VAPOR IN THE PRODUCED PART. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START-UP. THIS TYPE OF CONDITION IS COSMETIC AND DOES NOT POSE A RISK TO THE CUSTOMER. THE ROOT CAUSE FOR THE FOREIGN MATTER IN FLUID PATH AND FOREIGN MATTER NON-FLUID PATH ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. PLEASE NOTE THAT SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION OF MORE THAN 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309605, LOT NUMBERS 4122257, 4214769, 4214768, 4192356, 4214780 AND 4262197. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECTS. ALL BATCHES WERE INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITIONS 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

    MATERIAL#: 309605, LOT#: 4122257, 4214769, 4214768, 4192356, 4214780. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. CUSTOMER HAS NOTED BLACK RESIDUE ON THE STOPPER OF SKU#: 309605. THE HAVE RETAINED APPROXIMATELY 5-6 INDIVIDUAL SYRINGES WITH THIS RESIDUE. THE RESIDUE WAS TESTED AND FOUND TO BE SILICON. THEY ALSO OBSERVED A FEW INSTANCES OF SMALL, WHITE PARTICLES ON THE INSIDE OF A FEW SYRINGES AS WELL. LOT#: 4122257, 4214769, 4214768, 4192356, 4214780.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001567 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4192356 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown