BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 21913536 · Received April 25, 2025

    Report

    Report Number
    9614033-2025-00036
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 13, 2025
    Report Date
    June 3, 2025
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    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

    SEVEN SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE SAMPLES WERE SENT FOR TESTING AND IT WAS OBSERVED THAT FIVE OF THE SEVEN SAMPLES HAVE A DEFECT IN THE TIP OF THE SYRINGE; THEREFORE, THE REPORTED INCIDENT COULD BE VERIFIED AS LEAK TESTING WAS ALSO PERFORMED AND THE DEFECT LED TO THE LEAKAGE AS REPORTED IN THE COMPLAINT. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THE DEFECT IS LINKED TO THE MANUFACTURING PROCESS WHEN THE SYRINGE TIP IS FORMED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL 200 S/C HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309657 LOT #UNKNOWN VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCTCOMPLAINT - CUSTOMER CALLED TO REPORT THAT THE NURSES REPORTED THAT THEY HAVE EXPERIENCED LEAKAGES USING THE SYRINGE. THE LEAKAGE IS NOT PAST THE PLUNGER, THEY THINK ITS ON THE HUB. HOWEVER, THE CUSTOMER DOES NOT KNOW THE EXACT LOT, PROVIDED TWO LOT NUMBERS 4232204 AND 4232239. SAMPLES ARE AVAILABLE FOR RETURN, NO PT HARM REPORTED. CUSTOMER WOULD LIKE TO KNOW IF THERE HAS BEEN OTHER REPORTS REGARDING 3ML LUERLOKS. ADDITIONAL INFORMATION PROVIDED: I HAVE THE TWO LATEST SYRINGES/SAMPLES THAT I WILL SEND IN WITH THE DATES OF (B)(6) 2025/(B)(6) 2025. THERE ARE THREE SAMPLES IN TOTAL AT THIS TIME, ONE OF SYRINGES ALREADY HAD THE PRESCRIPTION LABEL REMOVED FOR HIPPA PURPOSES, SO NO DATE ON THAT ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825529 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown