BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SER PLASTIPAK 5ML LS 40X8 AL

    MDR report key: 19509231 · Received June 11, 2024

    Report

    Report Number
    3003916417-2024-00153
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    April 4, 2024
    Report Date
    July 17, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463002389
    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 AND PHOTO RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, SYRINGE IS OBSERVED WITH NEEDLE, AS THE PLUNGER IS BEING PUSHED DOWN, THE NEEDLE AND SYRINGE SEPARATES, CAUSING LEAKAGE. PHYSICAL SAMPLE IS REQUIRED TO FURTHER ANALYZE AND PERFORM FUNCTIONAL TESTING ON THE PRODUCT TO DETERMINE ROOT CAUSE. 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. IT IS IMPORTANT TO FOLLOW THE INSTRUCTIONS FOR USE TO ENSURE THE PRODUCT FUNCTIONS PROPERLY, THIS SYRINGE PRODUCT IS FOR SINGLE USE. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SER PLASTIPAK 5ML LS 40X8 AL PLUNGER MOVEMENT WAS DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM SPANISH TO ENGLISH: I AM SENDING EVIDENCE OF THE SITUATION THAT HAS BEEN OCCURRING SINCE THE NEW 5ML SYRINGES BEGAN TO BE USED. 1. THE LAST PURCHASE MADE BEFORE THE CHANGE WAS MADE ON 01 AUGUST 2023, WITH THE CODE 302495 AS SHOWN ON THE INVOICE (B)(4). 2. THE PURCHASE MADE IN THE MONTH OF FEBRUARY 2024 WAS MADE WITH THE CHANGE MADE IN THE CODE 990337 AS SHOWN ON THE INVOICE (B)(4). 3. ACCORDING TO COMMUNICATION SENT BY YOU LAST AUGUST 2023, THIS REFERENCE WOULD NOT PRESENT ANY CHANGE ONLY OF THE CODE NUMBER AS SHOWN IN THE ANNEX LETTER BECTON, THEREFORE A PURCHASE OF (B)(4) UNITS WAS MADE IN THE MONTH OF FEBRUARY 2024. THAT IS, IT SHOULD BE THE SAME PRODUCT THAT WE USED AND THAT WE DID NOT HAVE ANY ABNORMALITIES IN THE PROCESS. 4. TO DATE THERE HAVE BEEN SEVERAL PROBLEMS WITH THE SYRINGE SINCE DUE TO THE PRESSURE AT THE TIME OF DOSING THEY ARE EXPLODING AND SPILLING PRODUCT, IN OUR CASE RADIOACTIVE THAT IS CONTAMINATING PERSONNEL AND EQUIPMENT. SUPPORT OF THE PRESENTED SITUATION IS SENT. ADDITIONAL INFORMATION RECEIVED ON 31 MAY 2024: DATE OF EVENT IDENTIFIED? 04/04/24 QUANTITY AFFECTED? 900 THAT HAVE ALREADY BEEN USED IS THERE ANY PATIENT INVOLVED, IF YES DESCRIBE IN DETAIL - NO HAS THERE BEEN ANY HARM TO PATIENTS/HEALTHCARE PROFESSIONALS, IF YES DESCRIBE IN DETAIL - AN EMPLOYEE OF THE COMPANY WAS CONTAMINATED WITH RADIOACTIVE MATERIAL BECAUSE HER SYRINGE EXPLODED AND THE RADIOACTIVE MATERIAL SPILLED ON HER HANDS. IS THE PHYSICAL SAMPLE AVAILABLE FOR RETURN FOR EVALUATION? YES IF YES, HOW MANY UNITS ARE AVAILABLE FOR COLLECTION? 2100 UNITS SAMPLE IS CONTAMINATED, IF YES INFORM THE SUBSTANCE. NO ADDITIONAL INFORMATION PROVIDED ON 06/05/2024: ¿ WAS THERE BLOOD OR CHEMOTHERAPY EXPOSURE TO THE MUCOUS MEMBRANES (EYES, NOSE AND MOUTH) OR SKIN? IF SO, REPORT ON THE MEASURES TAKEN. (DETAIL). NO, THE STAFF WAS EXPOSED TO RADIOACTIVE MATERIAL, WHEN THE WORKER PRESENTED THE INCIDENT HE HAD TO CARRY OUT A DECONTAMINATION PROCESS ON HIS HANDS, BECAUSE EVEN THOUGH DOUBLE GLOVES WERE USED, IT GOT TO THE SKIN. ¿ WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT HAPPENED TO THAT EMPLOYEE (DIAGNOSTIC IMAGING, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) NO. ¿ WHAT MEDICATION WAS BEING ADMINISTERED? SESTAMIBI WAS BEING DOSED WITH TECHNETIUM (RADIOACTIVE PRODUCT SESTAMIBI-TC-99M

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294896 BD SER PLASTIPAK 5ML LS 40X8 AL SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 2118967 07891463002389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown