BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 12064121 · Received June 24, 2021

    Report

    Report Number
    1213809-2021-00453
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 27, 2021
    Report Date
    August 27, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: MEDICAL DEVICE LOT #: 0323681, MEDICAL DEVICE EXPIRATION DATE: 10/31/2025, DEVICE MANUFACTURE DATE: 11/18/2020. MEDICAL DEVICE LOT #: 0213251, MEDICAL DEVICE EXPIRATION DATE: 6/30/2025, DEVICE MANUFACTURE DATE: 7/31/2020. DEVICE AVAILABLE FOR EVAL?: YES. RETURNED TO MANUFACTURER ON: 8/9/2021. INVESTIGATION: TEN SEALED PACKAGED 5ML SYRINGES WERE RECEIVED, 5 FROM BATCH #0213251 AND 5 FROM BATCH #0323681 (P/N 309649). THE SAMPLES WERE TESTED FOR LEAKAGE PAST STOPPER PER PROCEDURE. ALL FIVE SYRINGES FROM BATCH 0213251 PASSED THE TEST WITH NO LEAKAGE OBSERVED. THREE SYRINGES FROM BATCH 0323681 PASSED THE TEST. ONE SYRINGE FROM BATCH 0323681 HAD LEAKAGE PAST FIRST RIB, ONE SYRINGE FROM BATCH 0323681 HAD LEAKAGE PAST SECOND RIB. THE AFFECTED SYRINGES COMPONENTS WERE EVALUATED UNDER MAGNIFICATION. NO DAMAGE WAS OBSERVED ON ANY COMPONENTS. NO FOREIGN MATTER AND NO MOLDING DEFECTS WERE OBSERVED. POTENTIAL ROOT CAUSE FOR THE LEAKAGE PAST STOPPER DEFECT COULD NOT BE DETERMINED. NO DEFECTS WERE CONFIRMED FOR BATCH 0213251. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD LUER-LOK¿ TIP SYRINGES LEAKED PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE FOLLOWING PRODUCT(S) MADE IN 5ML SYRINGES, WERE REJECTED EITHER IN PROCESS OR AT RELEASE DUE TO FLUID (PRODUCT) SEEPING INTO THE BUNG. IT APPEARED TO SEEP INTO THE BUNG AS A RESULT OF CAPPING THE SYRINGE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 BD LUER-LOK¿ TIP SYRINGES LEAKED PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE FOLLOWING PRODUCT(S) MADE IN 5ML SYRINGES, WERE REJECTED EITHER IN PROCESS OR AT RELEASE DUE TO FLUID (PRODUCT) SEEPING INTO THE BUNG. IT APPEARED TO SEEP INTO THE BUNG AS A RESULT OF CAPPING THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953180 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309649 UNKNOWN 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1