BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL BNS

    MDR report key: 18256117 · Received December 4, 2023

    Report

    Report Number
    1911916-2023-00872
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 9, 2023
    Report Date
    December 5, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903010313
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED UNITS HAD A SCALE MARKING ISSUE. TO AID IN THE INVESTIGATION, THREE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. EACH SAMPLE HAS A SCALE MARKING ISSUE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE SYRINGE BARREL PRINTING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301031, LOT 3110630. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENT REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    PR (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. PATIENT PROBLEM CODE: F26 ¿ NO HEALTH CONSEQUENCES OR IMPACT DEVICE PROBLEM CODE: A020102 - NONSTANDARD DEVICE.

    Description of Event or Problem · 0

    (B)(4) NO ADDITIONAL INFORMATION RECEIVED. THE CUSTOMER RETURNED SAMPLES WITH A SCALE MARKING ISSUE THAT WERE NOT ORIGINALLY REPORTED FOR THIS COMPLAINT - THEY ALSO CONFIRMED THAT THE SAMPLES DO NOT PERTAIN TO ANY OTHER PR. SINCE THE AWARENESS DATE OF THE SCALE MARKING ISSUE WAS NOT UNTIL THE SAMPLES WERE RECEIVED, WE WILL NEED A NEW PR FOR THIS DEFECT. WOULD YOU PLEASE OPEN A NEW PR WITH THE AWARENESS DATE OF NOVEMBER 9TH FOR SCALE MARKING ISSUE?

    Description of Event or Problem · 0

    THE CUSTOMER RETURNED SAMPLES WITH A SCALE MARKING ISSUE THAT WERE NOT ORIGINALLY REPORTED FOR THIS COMPLAINT - THEY ALSO CONFIRMED THAT THE SAMPLES DO NOT PERTAIN TO ANY OTHER PR. SINCE THE AWARENESS DATE OF THE SCALE MARKING ISSUE WAS NOT UNTIL THE SAMPLES WERE RECEIVED, WE WILL NEED A NEW PR FOR THIS DEFECT. WOULD YOU PLEASE OPEN A NEW PR WITH THE AWARENESS DATE OF NOVEMBER 9TH FOR SCALE MARKING ISSUE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450778 SYRINGE 20ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON 3110630 50382903010313

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown