BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 17916948 · Received October 11, 2023

    Report

    Report Number
    3003916417-2023-00301
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 27, 2023
    Report Date
    January 8, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463003782
    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

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGES HAD DIFFICULT WITH PLUNGER MOVEMENT AND THERE WERE AIR BUBBLES. THE FOLLOWING WAS TRANSLATED FROM SPANISH TO ENGLISH: "ISSUES PRESENTED WITH THE BD 20 CC SYRINGE CODE 990687 SINCE THIS SYRINGE IS USED TO ADMINISTER MEDICATIONS THROUGH CHANNEL B OF THE PLUM-A 360 PUMP, A TASK THAT IS NOT EFFECTIVE SINCE THE SYRINGE PLUNGER REMAINS STUCK , FILLED WITH AIR, SO THE PUMP ACTIVATES THE ALARM DUE TO PROXIMAL OCCLUSION OR AIR, GENERATING MANY DELAYS IN THE ADMINISTRATION OF MEDICATIONS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFO.

    Description of Event or Problem · 0

    "ISSUES PRESENTED WITH THE BD 20 CC SYRINGE CODE (B)(4) SINCE THIS SYRINGE IS USED TO ADMINISTER MEDICATIONS THROUGH CHANNEL B OF THE PLUM-A 360 PUMP, A TASK THAT IS NOT EFFECTIVE SINCE THE SYRINGE PLUNGER REMAINS STUCK , FILLED WITH AIR, SO THE PUMP ACTIVATES THE ALARM DUE TO PROXIMAL OCCLUSION OR AIR, GENERATING MANY DELAYS IN THE ADMINISTRATION OF MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118969 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA UNK 07891463003782

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown