BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    50 ML BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 13254544 · Received January 13, 2022

    Report

    Report Number
    3003152976-2021-00901
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    December 20, 2021
    Report Date
    March 2, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2008337 , MEDICAL DEVICE EXPIRATION DATE: 2025-07-31 , DEVICE MANUFACTURE DATE: 2020-08-07. MEDICAL DEVICE LOT #: 2103502, MEDICAL DEVICE EXPIRATION DATE: 2026-02-28 , DEVICE MANUFACTURE DATE: 2021-03-23 . A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 2022-01-24. H6: INVESTIGATION SUMMARY FIFTEEN UNUSED SAMPLES SEPARATED IN THREE BAGS WITH FIVE SYRINGES EACH RECEIVED FOR INVESTIGATION. ONE BAG WITH FIVE SYRINGES BELONG TO LOT 2109085, ANOTHER BAG FROM LOT 2103502, THE THIRD BAG HAVE FIVE SYRINGES WITH TWO LOT NUMBERS: 2008337 OR 2103502. LOT 2109085 WAS SENT BY CUSTOMER FOR COMPARISON PURPOSES. UPON VISUAL INSPECTION OF THE SAMPLES, NO DEFECTS OR ISSUES OBSERVED. STOPPER IS CORRECTLY ASSEMBLED. FUNCTIONAL TESTING IS PERFORMED, NO LEAKAGE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 2008337,2103502 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, INCLUDING LEAKAGE TESTING TO VERIFY THE STOPPER SEAL. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 50 ML BD PLASTIPAK¿ LUER-LOK¿ SYRINGES EXPERIENCED LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE DRAWING UP CYTOSTATICS, MY COLLEAGUE FELT THAT SHE WAS DRAWING SOME AIR, THEN LIQUID ALONG THE PLUNGER ENTERED THE SYRINGE. AND LIQUID RAN ONTO HER GLOVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 50 ML BD PLASTIPAK¿ LUER-LOK¿ SYRINGES EXPERIENCED LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE DRAWING UP CYTOSTATICS, MY COLLEAGUE FELT THAT SHE WAS DRAWING SOME AIR, THEN LIQUID ALONG THE PLUNGER ENTERED THE SYRINGE. AND LIQUID RAN ONTO HER GLOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018134 50 ML BD PLASTIPAK¿ LUER-LOK¿ SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown