BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 17691494 · Received September 6, 2023

    Report

    Report Number
    3003916417-2023-00267
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 18, 2023
    Report Date
    November 13, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VIDEO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, SYRINGE IS ATTACHED TO THE PUMP, OCCLUSION SOUND SIS HEARD, UNABLE TO CONFIRM DIFFICULT IN THE PLUNGER MOVEMENT. FURTHERMORE, 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. PHYSICAL SAMPLE IS REQUIRED TO FURTHER ANALYZE. 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.

    Additional Manufacturer Narrative · 0

    H.3. 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

    THE BD 20ML SYRINGE WITHOUT NEEDLE CODE 1000000546 LOT: 2202303 REF: 990687 WHEN USED WITH AN INFUSION PUMP IN PORT B OR IN A BRAUN PERFUSOR IT PRESENTS HIGH PRESSURE DUE TO OBSTRUCTION WITHOUT HAVING IT, THERE IS DIFFICULTY WITH THE MANIPULATION OF THE PLUNGER, A RESISTANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HAD DIFFICULT PLUNGER MOVEMENT DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "THE BD 20ML SYRINGE WITHOUT NEEDLE CODE 1000000546 LOT: 2202303 REF: (B)(4) WHEN USED WITH AN INFUSION PUMP IN PORT B OR IN A BRAUN PERFUSOR IT PRESENTS HIGH PRESSURE DUE TO OBSTRUCTION WITHOUT HAVING IT, THERE IS DIFFICULTY WITH THE MANIPULATION OF THE PLUNGER, A RESISTANCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248988 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 2202303

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown