BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 9873422 · Received March 24, 2020

    Report

    Report Number
    3003152976-2020-00140
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    November 6, 2019
    Report Date
    April 22, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 1908256, 1905234, 1907223,1902225, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF EACH LOT WERE USED TO CONDUCT A LEAKAGE TEST. ALL PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS IDENTIFIED. THE SAMPLES WERE DISASSEMBLED, NO DAMAGE WAS OBSERVED IN THE PLUNGER ROD, THE STOPPERS WAS PROPERLY ASSEMBLED TO THE PLUNGER, AND NO LEAKAGES OCCURRED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CYTOTOXIC MEDICATION LEAKED PAST THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE STOPPER DURING USE. LOT# 1908256 WAS REPORTED TO HAVE HAD 2 OCCURRENCES OF THIS EVENT, WHILE LOT#S 1905234, 1907223, AND 1902225 WERE REPORTED TO HAVE HAD AN UNSPECIFIED NUMBER OF OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "CYTOTOXIC LEAKAGE PAST STOPPER".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1908256, MEDICAL DEVICE EXPIRATION DATE: 2024-07-31, DEVICE MANUFACTURE DATE: 2019-08-05, MEDICAL DEVICE LOT #: 1905234, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: 2019-05-16, MEDICAL DEVICE LOT #: 1907223, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2019-07-10, MEDICAL DEVICE LOT #: 1902225, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-02-12. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CYTOTOXIC MEDICATION LEAKED PAST THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE STOPPER DURING USE. LOT# 1908256 WAS REPORTED TO HAVE HAD 2 OCCURRENCES OF THIS EVENT, WHILE LOT#S 1905234, 1907223, AND 1902225 WERE REPORTED TO HAVE HAD AN UNSPECIFIED NUMBER OF OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "CYTOTOXIC LEAKAGE PAST STOPPER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339509 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other