BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 14502636 · Received May 25, 2022

    Report

    Report Number
    3003152976-2022-00233
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 7, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2111033. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2026. DEVICE MANUFACTURE DATE: 15-NOV-2021. MEDICAL DEVICE LOT #: 2110043. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026. DEVICE MANUFACTURE DATE: 06-OCT-2021. MEDICAL DEVICE LOT #: 2108032. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2026. DEVICE MANUFACTURE DATE: 19-AUG-2021. 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

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION HAVE BEEN PROVIDED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 2110043, 21110033 AND 210803, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES OF EACH LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE VISUALLY INSPECTED, NO FOREIGN MATTER OR OTHER LIQUID WAS OBSERVED INSIDE ANY OF THE SYRINGES. AS NO DEFECT WAS OBSERVED IN THE RETAINED SAMPLES AND DEVICE RECORDS DO NOT INDICATE ANY ISSUES OCCURRED DURING MANUFACTURING, A DEFINITIVE ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LIQUID WAS FOUND WITHIN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ONE NURSE HAD THE IMPRESSION OF SEEING A SCRATCH IN THE BODY OF THE SYRINGE AND ON CLOSER EXAMINATION THE PRESENCE OF A LIQUID IN THE SYRINGE; LIQUID THAT CAME OUT OF THE SYRINGE AFTER PUSHING ON THE PLUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LIQUID WAS FOUND WITHIN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ONE NURSE HAD THE IMPRESSION OF SEEING A SCRATCH IN THE BODY OF THE SYRINGE AND ON CLOSER EXAMINATION THE PRESENCE OF A LIQUID IN THE SYRINGE; LIQUID THAT CAME OUT OF THE SYRINGE AFTER PUSHING ON THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393074 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown