BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 17796010 · Received September 21, 2023

    Report

    Report Number
    3003916417-2023-00284
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    September 7, 2023
    Report Date
    November 2, 2023
    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
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, BOX WITH MATERIAL NUMBER 990687 IS DISPLAYED, ADDITIONALLY A SYRINGE IS DISPLAYED. NO DEFECTS OR ISSUES OBSERVED. UNABLE TO CONFIRM FAILURE BASED ON IMAGES. PHYSICAL SAMPLE IS REQUIRED TO FURTHER ANALYZE. 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. 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

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    ADDITIONAL INFORMATION RECEIVED. WHEN INFUSING ANESTHESIA UNDER MANUAL PRESSURE, THE NURSE NOTICES THAT THE PLUNGER IS TOO HARD. WHEN SHE TRIES TO APPLY MORE PRESSURE, SHE OVERDOES IT. CUSTOMER SENT TO US THE INFORMATION BELOW ON (B)(6) 2023. - WAS THE REPORTED INCIDENT NOTICED BEFORE, DURING OR AFTER USE? DURING USE. - HAS THERE BEEN ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? (DETAIL) THE PATIENT WAS GIVEN MORE ANESTHESIA THAN SHOULD BE. - WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT OCCURRED (IMAGING EXAMINATIONS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) NO. - HAS THERE BEEN EXPOSURE OF BLOOD OR CHEMOTHERAPY TO THE MUCOUS MEMBRANES OR SKIN? (DETAIL) NO. - COULD YOU SEND A VIDEO DEMONSTRATING THE REPORTED INCIDENT? WE HAVE NO VIDEO, ONLY PHOTOS OF THE SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PLUNGER WAS DIFFICULT TO MOVE WHILE INFUSING ANESTHESIA UNDER MANUAL PRESSURE. THIS OCCURRED WITH 23 SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "WHEN INFUSING ANESTHESIA UNDER MANUAL PRESSURE, THE NURSE NOTICES THAT THE PLUNGER IS TOO HARD. WHEN SHE TRIES TO APPLY MORE PRESSURE, SHE OVERDOES IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712409 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 2139658 07891463003782

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown