BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 20179681 · Received September 10, 2024

    Report

    Report Number
    1911916-2024-00662
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 26, 2024
    Report Date
    September 27, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT WAS REPORTED SYRINGES WERE FOUND WITH A DIFFERENT PACKAGING, DRAWING NUMBER AND TRADEMARK DATES. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS TWO PACKAGING BLISTER TOP WEBS. ONE HAS GRAPHICS BLUE IN COLOR AND THE OTHER BLISTER HAS GRAPHICS IN BLACK. BOTH GRAPHICS ARE APPROVED; THEY ARE JUST PRINTED ON DIFFERENT PACKAGING EQUIPMENT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOTS 4143054 AND 4121590. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOT. NO FURTHER ACTION IS REQUIRED AT THIS TIME. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD IS CONFIRMED, BUT ACCEPTABLE.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. ADDITIONAL BATCH REPORTED: BATCH: 4143054 BATCH CREATION DATE: 2024-05-24 BATCH EXPIRATION DATE: 2029-04-30.

    Description of Event or Problem · 0

    MATERIAL #: 309653; BATCH #: 4143054, 4121590. IT WAS REPORTED BY THE CUSTOMER THAT PART NUMBER 0130408-1 WAS FOUND WITH A DIFFERENT PACKAGING, DRAWING NUMBER AND TRADEMARK DATES. RCC RECEIVED A COMPLAINT VIA EMAIL. PART NUMBER 0130408-1 WAS FOUND WITH A DIFFERENT PACKAGING, DRAWING NUMBER AND TRADEMARK DATES. PLEASE SEE ATTACHED IMAGED FOR LOT NUMBER 4143054 (BATCH WAS PART OF (B)(4)) AND 4121590 (BATCH WAS PART OF (B)(4)).

    Description of Event or Problem · 0

    MATERIAL #: 309653 BATCH #: 4143054, 4121590. IT WAS REPORTED BY THE CUSTOMER THAT PART NUMBER 0130408-1 WAS FOUND WITH A DIFFERENT PACKAGING, DRAWING NUMBER AND TRADEMARK DATES. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED PART NUMBER 0130408-1 WAS FOUND WITH A DIFFERENT PACKAGING, DRAWING NUMBER AND TRADEMARK DATES. PLEASE SEE ATTACHED IMAGED FOR LOT NUMBER 4143054 (BATCH WAS PART OF PO (B)(4) .(BATCH WAS PART OF PO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2332133 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4121590 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown