BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 22138169 · Received June 3, 2025

    Report

    Report Number
    1213809-2025-00371
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 15, 2025
    Report Date
    July 7, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    PR 12073426 FOLLOW UP REPORT FOR CORRECTION. MFR REPORT # 9614033-2025-00077 WAS SUBMITTED AS THE SITE LEGAL NAME WAS INCORRECTLY REPORTED AS CANAAN IN THE INITIAL MDR SUBMISSION, 1213809-2025-00371. MFR REPORT # 9614033-2025-00077 WAS SUBMITTED TO UPDATE THE SITE LEGAL NAME TO CUAUTITLAN, AND TO HAVE THE PROPER MFR NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL 200 S/C HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309657, BATCH#: 4197051. IT WAS REPORTED BY CUSTOMER THAT LEAKING AROUND THE AREA THAT CONNECTS TO THE NEEDLE. FOUND BEFORE IT WAS USED ON THE PATIENT LIDOCAINE. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. 309628 LOT: 4250927. THEY ARE LEAKING AROUND THE AREA THAT CONNECTS TO THE NEEDLE. FOUND BEFORE IT WAS USED ON THE PATIENT BOTOX. 309657 LOT UNKNOWN. DISCARD BOXES BECAUSE TRYING TO FIND ONE THAT DID NOT LEAK. NO SAMPLES AVAILABLE. ADDITIONAL INFORMATION PROVIDED: MY ORIGINAL CALL WAS TO REPORT THE 1CC BD SYRINGE, 3CC BD SYRINGE, THE 33G ½ NEEDLES. THE 1CC SYRINGE USED WITH THE 33G ½ NEEDLE WAS DRIPPING SOME BOTOX AT THE TIME OF INJECTING THE PT. A VERY FEW TIMES THE 3CC SYRINGES WOULD ALSO LEAK WHEN INJECTING LIDOCAINE. ( USING THE SAME 33G NEEDLES). 1ML BD SYRINGE LOT# 424803314, 3ML BD SYRINGE LOT3 4197051, TSK STERIJECT 33G X1/2 IN LOT # 210482.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588442 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4197051 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown