BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL W/NDL 21GX1IN

    MDR report key: 18865110 · Received March 8, 2024

    Report

    Report Number
    9614033-2024-00025
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 19, 2024
    Report Date
    April 3, 2024
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903096428
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21GX1IN HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD A CLINIC FILE A COMPLAINT FOR FAULTY BD 10 ML SYRINGE LUER-LOCK TIP WITH BD PRECISION GLIDE NEEDLE. THE CLINIC REPORTED THAT MULTIPLE SYRINGES WERE LEAKING FROM THE STOPPER. THERE WAS ONLY ONE CLINIC WHO REPORTED THIS ISSUE AT THIS TIME." PLEASE SEE PRODUCT AND LOT INFORMATION BELOW PRODUCT: 10 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 21 G X 1 IN. MFR PART #: 30964220 LOT#: 3233242 CAN YOU PLEASE FORWARD/SHARE WITH THE APPROPRIATE PARTIES FROM BD TO ADDRESS THIS ISSUE. ALSO, HAVE YOU HEARD OF ANY OTHER CUSTOMERS COMPLAIN ABOUT THIS PRODUCT/LOT NUMBER. ADDITIONAL INFORMATION PROVIDED ON 02/21/2024: 1. CAN YOU PLEASE PROVIDE A EXACT DATE OF EVENT? A. I BELIEVE MONDAY, (B)(6) 2024. 2. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? A. MULTIPLE SYRINGES LEAKING FROM STOPPER ¿ SAME LOT: 3233242. 3. WHERE SPECIFICALLY WAS THE LEAKAGE? A. STOPPER. 4. WERE THERE ANY NOTICEABLE DEFECTS ON THE LUER / STOPPER / CONNECTION / NEEDLE? A. NOT TO MY KNOWLEDGE. 5. IF PAST THE STOPPER, WAS IT ALL THE WAY PAST THE STOPPER OR ONLY WITHIN THE RIBS OF THE STOPPER? A. IT WAS AT THE STOPPER. 6. WHAT WAS BEING USED IN THE SYRINGE? A. I¿M NOT SURE. 7. DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? A. NO, NOT TO MY KNOWLEDGE. 8. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? A. NO, NOT TO MY KNOWLEDGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882217 BD SYRINGE 10ML LL W/NDL 21GX1IN PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 3233242 00382903096428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown