BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL BNS

    MDR report key: 17950626 · Received October 17, 2023

    Report

    Report Number
    1911916-2023-00777
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    October 6, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903010313
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS A DAMAGED SYRINGE, CROOKED SCALES AND A MISSING STOPPER. TO AID IN THE INVESTIGATION, SIX SAMPLES WITH NO PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. FOUR SAMPLES HAVE A SCALE MARKING ISSUE, ONE SAMPLE IS MISSING THE STOPPER, AND ONE SAMPLE HAS RUB MARKS AT THE TOP PART OF THE SYRINGE BARREL. RUB MARKS ARE CONSIDERED AN ACCEPTABLE IMPERFECTION. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SCALE MARKING DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE SYRINGE BARREL PRINTING PROCESS. THE MISSING STOPPER COULD OCCUR IF THERE WAS A JAM DURING THE PLUNGER ROD-RUBBER STOPPER ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301031, POSSIBLE LOTS 2032050 AND 2032058. 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. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. 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. DEVICE PROBLEM CODE: A0201 - PRODUCT QUALITY PROBLEM PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT POSSIBLE LOTS - UNKNOWN WHICH LOT WAS USED: 2032050 . 2032058.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. AS AGREED, AT THE END OF THE BATCH WE REPORT THE DISCREPANCIES FOUND. ALL REPORTS WERE DISCOVERED DURING PACKAGING, I.E. BEFORE USE. NO PATIENTS INVOLVED. ARTICLE CODE: 301031 LL BNS 20ML SYRINGE. BATCH: 2032050 & 2032058. DAMAGED SYRINGE X 1. CROOKED SCALE X 4. MISSING STOPPER X 1. SAMPLES ARE AVAILABLE AND CAN BE PICKED UP IF NEEDED.

    Description of Event or Problem · 0

    AS AGREED, AT THE END OF THE BATCH WE REPORT THE DISCREPANCIES FOUND. ALL REPORTS WERE DISCOVERED DURING PACKAGING, I.E. BEFORE USE. NO PATIENTS INVOLVED. ARTICLE CODE: 301031 LL BNS 20ML SYRINGE. BATCH: 2032050 & 2032058. DAMAGED SYRINGE X 1. CROOKED SCALE X 4 . MISSING STOPPER X 1. SAMPLES ARE AVAILABLE AND CAN BE PICKED UP IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749967 SYRINGE 20ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON UNKNOWN 50382903010313

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown