BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 11616771 · Received April 5, 2021

    Report

    Report Number
    3003152976-2021-00182
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 10, 2021
    Report Date
    May 24, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/21/2021. H.6. INVESTIGATION: SAMPLES WERE PROVIDED. THIS INVESTIGATION IS PERFORMED WITH THESE SAMPLES AND REVIEWING DHR OF THE LOTS AFFECTED BY THIS COMPLAINT, 2010077, AND 2011007. FOUR SYRINGES WERE PROVIDED WITH THREE LOT NUMBERS, DEVICES CANNOT BE IDENTIFIED WITH ITS LOT NUMBER AS THEY WERE SENT TOGETHER. THEREFORE, THE FOUR SAMPLES ARE EVALUATED. FOR THIS COMPLAINT, A PICTURE WAS ALSO PROVIDED. UPON VISUAL INSPECTION OF THE SAMPLES, IN THE FOUR OF THEM IT CAN BE SEEN LEAKAGE OF A WHITE SUBSTANCE PAST THE STOPPER. IN THE PICTURE PROVIDED BY CUSTOMER IT CAN BE CONFIRMED THERE IS LEAKAGE PAST THE STOPPER. MOREOVER, NO DAMAGE OR MOLDING DEFECT CAN BE OBSERVED IN THE SYRINGES THAT COULD HAVE CAUSE LEAKAGE. THE PLUNGER IS CORRECTLY ASSEMBLED TO THE PLUNGER IN ALL THE SAMPLES. DHR OF LOT 2010077 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. LEAK TEST IS CARRIED OUT WITH THE FOUR SAMPLES. ALL TESTED SAMPLES MET SPECIFICATIONS. LEAK WAS OBSERVED IN PHOTO. SINCE NO MANUFACTURING DEFECT CAN BE OBSERVED IN VISUAL INSPECTION OF THE RETAINED SAMPLES EVALUATED AND THEY MEET STANDARDS FOR LEAK TEST, THE ROOT CAUSE OF THE ALLEGED DEFECT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE FROM LOT 2011007, AND 1 SYRINGE FROM LOT 2010077 LEAKED WHEN PULLING UP LIQUID. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "SYRINGE LEAKS WHEN PULLING UP LIQUID. THESE SYRINGES HAVE BEEN USED TO DRAW UP PROPOFOL."

    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 #: 2011007. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. DEVICE MANUFACTURE DATE: 2020-10-30. MEDICAL DEVICE LOT #: 2010077. MEDICAL DEVICE EXPIRATION DATE: 2025-09-30. DEVICE MANUFACTURE DATE: 2020-10-19. 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 1 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE FROM LOT 2011007, AND 1 SYRINGE FROM LOT 2010077 LEAKED WHEN PULLING UP LIQUID. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "SYRINGE LEAKS WHEN PULLING UP LIQUID. THESE SYRINGES HAVE BEEN USED TO DRAW UP PROPOFOL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510185 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1