BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOCK¿ SYRINGE

    MDR report key: 17568619 · Received August 17, 2023

    Report

    Report Number
    9614033-2023-00082
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    August 1, 2023
    Report Date
    November 9, 2023
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    07891463003782
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION D.4. MEDICAL DEVICE LOT 2046808 D.4 DEVICE EXPIRATION DATE: 02/28/2027 H.4. DEVICE MANUFACTURE DATE: 02/15/2022 INVESTIGATION SUMMARY: PHOTO RECEIVED, THROUGH VISUAL EVALUATION, SYRINGE IS OBSERVED, UNABLE TO CONFIRM INCIDENT BASED ON PHOTO. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2046808 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETENTION SAMPLES FROM THE SAME LOT WERE EVALUATED, NO DEFECTS OR ISSUES 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.

    Additional Manufacturer Narrative · 0

    PHOTO RECEIVED, THROUGH VISUAL EVALUATION, SYRINGE IS OBSERVED, UNABLE TO CONFIRM INCIDENT BASED ON PHOTO. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT #: LOT WAS REPORTED; HOWEVER, THIS IS NOT A LOT # 2046808 MANUFACTURED FOR THE REPORTED CATALOG #. D.4 DEVICE EXPIRATION DATE: UNKNOWN. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. THE 10 AND 20 ML SYRINGES ARE USED IN ARCOMED AND ATSA BRAND PERFUSERS, THE USE OF THE NEW VERSION MADE IN BRAZIL, OCCLUSION BRAND IN THESE EQUIPMENTS, THIS DID NOT HAPPEN WITH PLASTIPAK OF NATIONAL ORIGIN. "STOPS" ARE PERCEIVED IN THE SYRINGE WHERE THE PLUNGER AND STOPPER DO NOT ADVANCE SMOOTHLY AND FIRMLY. THE PROBLEM HAS OCCURRED IN DIFFERENT BATCHES OF THE SYRINGE. 17.OCT.23: ADD INFO RECEIVED. THE LOT NUMBER WAS PHYSICALLY CORROBORATED WITH THE PERSONNEL WHO ATTENDED TO VERIFY THE SYRINGES. THE TOTAL NUMBER OF UNITS THAT WERE IDENTIFIED WAS AROUND 20. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE ENDS BY RESETTING THE ALARMS. KIND OF ALARM: OCCLUSION ALARM. THE ALARM OCCURS RIGHT AT THE BEGINNING. THE SAMPLE WAS DELIVERED AT THE TIME. AS I MENTIONED AT THE BEGINNING, THE DEVIATION WAS GENERATED ONLY WITH THE SYRINGES COMING FROM BRAZIL. NOTE: AS THE CUSTOMER CONFIRMED THE BATCH NUMBER INFORMED: 2046808, THE MATERIAL NUMBER IS UPDATED TO 990687 (SYRINGE MANUFACTURED IN BRAZIL). THE CATALOG 302562 INITIALLY INFORMED IS MANUFACTURED IN MEXICO, THEREFORE CUSTOMER PROBABLY INFORMED THIS ONE ONLY FOR COMPARISON.

    Description of Event or Problem · 0

    THE 10 AND 20 ML SYRINGES ARE USED IN ARCOMED AND ATSA BRAND PERFUSERS, THE USE OF THE NEW VERSION MADE IN BRAZIL, OCCLUSION BRAND IN THESE EQUIPMENTS, THIS DID NOT HAPPEN WITH PLASTIPAK OF NATIONAL ORIGIN. "STOPS" ARE PERCEIVED IN THE SYRINGE WHERE THE PLUNGER AND STOPPER DO NOT ADVANCE SMOOTHLY AND FIRMLY. THE PROBLEM HAS OCCURRED IN DIFFERENT BATCHES OF THE SYRINGE. 17.OCT.23: ADD INFO RECEIVED. THE LOT NUMBER WAS PHYSICALLY CORROBORATED WITH THE PERSONNEL WHO ATTENDED TO VERIFY THE SYRINGES. THE TOTAL NUMBER OF UNITS THAT WERE IDENTIFIED WAS AROUND 20. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE ENDS BY RESETTING THE ALARMS. KIND OF ALARM: OCCLUSION ALARM. THE ALARM OCCURS RIGHT AT THE BEGINNING. THE SAMPLE WAS DELIVERED AT THE TIME. AS I MENTIONED AT THE BEGINNING, THE DEVIATION WAS GENERATED ONLY WITH THE SYRINGES COMING FROM BRAZIL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOCK¿ SYRINGE PLUNGER MOVEMENT DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE 10 AND 20 ML SYRINGES ARE USED IN ARCOMED AND ATSA BRAND PERFUSERS, THE USE OF THE NEW VERSION MADE IN BRAZIL, OCCLUSION BRAND IN THESE EQUIPMENTS, THIS DID NOT HAPPEN WITH PLASTIPAK OF NATIONAL ORIGIN. "STOPS" ARE PERCEIVED IN THE SYRINGE WHERE THE PLUNGER AND STOPPER DO NOT ADVANCE SMOOTHLY AND FIRMLY. THE PROBLEM HAS OCCURRED IN DIFFERENT BATCHES OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995124 BD LUER-LOCK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 2046808 07891463003782

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown