BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 17956855 · Received October 18, 2023

    Report

    Report Number
    1911916-2023-00783
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    October 12, 2023
    Report Date
    October 26, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A020102 - NONSTANDARD DEVICE. PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 0

    PR 9081353 FOLLOW UP REPORT IT WAS REPORTED BY THE CONSUMER THE SYRINGES ARE MISSING PRINTING LINES AND NUMBERS. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 3208287. THERE WAS DOCUMENTATION OF THIS TYPE OF DEFECT DURING THE PRODUCTION RUN OF THIS LOT. A QUALITY NOTIFICATION WAS ISSUED FOR THE SCALE MARKING ISSUE. IT COULD BE POSSIBLE THE CUSTOMER RECEIVED ESCAPES FROM THIS INCIDENT EXPERIENCED DURING PRODUCTION. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. H3 OTHER TEXT : SEE H10 NARRATIVE.

    Description of Event or Problem · 0

    MATERIAL#:309653. BATCH#:3208287. IT WAS REPORTED BY CUSTOMER THAT THEY HAVE NOTED THAT ON SOME OF THE BD 50ML SYRINGES NDC 08290-3096-80 THAT THE PRINTING OF THE LINES AND NUMBERS ARE MISSING IN SPOTS AND THEY HAVE HAD TO THROW THEM AWAY. TODAY THEY THREW OUT AT LEAST 30 AND THEY ALL HAD THE SAME LOT # WHICH IS 3208287 EXP DATE 6/30/2028. THEY HAVE NOT USED ANY OF THE SYRINGES THAT WERE NOTED TO HAVE MISSING LINES ORE NUMBERS, BUT WANTED TO REPORT THIS TO BD. VERBATIM: CUSTOMER STATED THAT WE HAVE NOTED THAT ON SOME OF THE BD 50ML SYRINGES NDC 08290-3096-80 THAT THE PRINTING OF THE LINES AND NUMBERS ARE MISSING IN SPOTS AND WE HAVE HAD TO THROW THEM AWAY. TODAY WE THREW OUT AT LEAST 30 AND THEY ALL HAD THE SAME LOT # WHICH IS 3208287 EXP DATE 6/30/2028. WE HAVE NOT USED ANY OF THE SYRINGES THAT WERE NOTED TO HAVE MISSING LINES ORE NUMBERS, BUT WANTED TO REPORT THIS TO YOUR COMPANY SO YOU CAN BE AWARE.

    Description of Event or Problem · 0

    PR 9081353 UPDATE - ADDITIONAL INFORMATION RECEIVED MATERIAL#:309653 BATCH#:3208287 IT WAS REPORTED BY CUSTOMER THAT THEY HAVE NOTED THAT ON SOME OF THE BD 50ML SYRINGES NDC 08290-3096-80 THAT THE PRINTING OF THE LINES AND NUMBERS ARE MISSING IN SPOTS AND THEY HAVE HAD TO THROW THEM AWAY. TODAY THEY THREW OUT AT LEAST 30 AND THEY ALL HAD THE SAME LOT # WHICH IS 3208287 EXP DATE 6/30/2028. THEY HAVE NOT USED ANY OF THE SYRINGES THAT WERE NOTED TO HAVE MISSING LINES ORE NUMBERS, BUT WANTED TO REPORT THIS TO BD. VERBATIM: CUSTOMER STATED THAT WE HAVE NOTED THAT ON SOME OF THE BD 50ML SYRINGES NDC 08290-3096-80 THAT THE PRINTING OF THE LINES AND NUMBERS ARE MISSING IN SPOTS AND WE HAVE HAD TO THROW THEM AWAY. TODAY WE THREW OUT AT LEAST 30 AND THEY ALL HAD THE SAME LOT # WHICH IS 3208287 EXP DATE 6/30/2028. WE HAVE NOT USED ANY OF THE SYRINGES THAT WERE NOTED TO HAVE MISSING LINES ORE NUMBERS, BUT WANTED TO REPORT THIS TO YOUR COMPANY SO YOU CAN BE AWARE. ADDITIONAL INFO FROM CUSTOMER: -WHAT IS THE TOTAL QUANTITY OF PRODUCTS FOUND DEFECTIVE? ~30 -IS THERE ANY ADVERSE EVENT OR SERIOUS INJURY OCCURRED? NO -WHAT IS THE EVENT DATE? 10/12/2023 -ARE YOU ABLE TO PROVIDE SAMPLE TO BD FOR INVESTIGATION? IF NO, CAN A PHOTO BE PROVIDED? IF YES, PLEASE PROVIDE MAILING ADDRESS. PRODUCTS WERE DISPOSED OF PRIOR TO STAFF TELLING ME. I CAN NOT PROVIDE A SAMPLE OR PHOTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539503 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 3208287 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown