BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ - 3-PIECE SYRINGE

    MDR report key: 13064719 · Received December 22, 2021

    Report

    Report Number
    3003152976-2021-00857
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    November 26, 2021
    Report Date
    January 11, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2012070, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, UPON VISUAL INSPECTION OF THE RETAINED SAMPLES REQUESTED NO DAMAGE CAN BE OBSERVED IN ANY OF THE INDIVIDUAL PARTS. STOPPER IS CORRECTLY ASSEMBLED IN THE TEN SYRINGES. THESE SYRINGES WERE DISASSEMBLED FINDING NO DAMAGE IN THE PLUNGER THAT COULD LEAD TO THE LEAKAGE EXPERIENCED BY CUSTOMER. LEAKAGE TEST WAS PERFORMED, NO LEAK OBSERVED. 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 AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    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 FLUID LEAKED PAST STOPPER DURING USE WITH A BD PLASTIPAK¿ - 3-PIECE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLUID COMING UP PAST BLACK PLUNGER WHEN SYRINGE BEING APPLIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FLUID LEAKED PAST STOPPER DURING USE WITH A BD PLASTIPAK¿ - 3-PIECE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLUID COMING UP PAST BLACK PLUNGER WHEN SYRINGE BEING APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957308 BD PLASTIPAK¿ - 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012070

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown