BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 16607644 · Received March 23, 2023

    Report

    Report Number
    3003152976-2023-00093
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    March 6, 2023
    Report Date
    May 12, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 27-MAR-2023. H6. INVESTIGATION SUMMARY: TWO USED SAMPLES RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, IT CAN BE OBSERVED LEAKAGE PAST THE STOPPER TOOK PLACE DURING USE. BARREL DO NOT PRESENT ANY DAMAGE THAT COULD HAVE DEFORMED THEIR SHAPE. THE STOPPER IS CORRECTLY ASSEMBLED, WHEN THE SYRINGE IS DISASSEMBLED THE PLUNGER DOES NOT SHOW ANY DEFECT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2211124, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TWO RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, ONE SAMPLE PRESENTED LEAKAGE. 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. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES LEAKED PAST THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "PREPARATION OF A VENOFER SYRINGE. THE SEAL IS NOT TIGHT, THE PRODUCT FLOWS OUT OF THE SYRINGE THROUGH THE PLUNGER. NEW PREPARATION WITH ANOTHER SYRINGE OF THE SAME BATCH: SAME THING. NO CONSEQUENCES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES LEAKED PAST THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "PREPARATION OF A VENOFER SYRINGE THE SEAL IS NOT TIGHT, THE PRODUCT FLOWS OUT OF THE SYRINGE THROUGH THE PLUNGER. NEW PREPARATION WITH ANOTHER SYRINGE OF THE SAME BATCH: SAME THING NO CONSEQUENCES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376947 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2211124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown