BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL W/NDL 18X1-1/2 RB

    MDR report key: 21849369 · Received April 16, 2025

    Report

    Report Number
    1213809-2025-00279
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    April 1, 2025
    Report Date
    June 6, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095804
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(6), SUPPLEMENTAL MDR, SILICONE VISIBLE. A VIDEO OF A 3 ML LUER-LOK SYRINGE WAS RECEIVED AND EVALUATED. THE VIDEO SHOWS A SINGLE SYRINGE WITH THE PLUNGER ROD BEING RETRACTED, DURING WHICH SILICONE STRINGING IS OBSERVED BETWEEN THE STOPPER AND THE TOP OF THE BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE SILICONE EXCESSIVE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. 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 WELL IN EXCESS OF 25 UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1242791. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 18X1-1/2 RB HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309580 , BATCH # 1242791. IT WAS REPORTED BY CUSTOMER THAT THICK LIQUID INSIDE SYRINGE. RCC RECEIVED A COMPLAINT VIA EMAIL. CONTACT NAME: XXX, CONTACT NUMBER: XXX, CONTACT EMAIL (IF AVAILABLE): XXX, ITEM(S): 309580, LOT(S): 1242791, DATE INCIDENT OCCURRED: (B)(6)2025. WAS THE PATIENT IMPACTED? WERE NOT ABLE TO USE IF YES, DESCRIBE: THICK LIQUID INSIDE SYRINGE IS A SAMPLE AVAILABLE? HAS VIDEO. CUSTOMER RESPONSE ON (B)(6) 2025. NOT A PROBLEM! ATTACHED PLEASE FIND THE VIDEO OF THE SYRINGE IN QUESTION. THIS VIDEO WAS TAKEN AFTER DRAWING AIR ONLY INTO THE SYRINGE (THE SYRINGE HAD NOT ENTERED ANY MEDICATION AND WAS FRESH OUT OF THE PACKAGING). I HAVE SEVERAL OTHER SYRINGES FROM THIS SAME LOT AND HAVE NOT EXPERIENCED THIS ISSUE YET IN ANY OTHER SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113710 BD SYRINGE 3ML LL W/NDL 18X1-1/2 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1242791 30382903095804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown