BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL CLEAR 14GA 1-1/4IN

    MDR report key: 11170428 · Received January 14, 2021

    Report

    Report Number
    3003152976-2021-00030
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Date of Event
    December 17, 2020
    Report Date
    January 29, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1911207, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THROUGHOUT THE MANUFACTURING PROCESS, FORCE TESTING AND SILICONE CONTENT TESTS ARE CONDUCTED FOR EACH LOT. TESTING RESULTS WERE REVIEWED FOR LOT 1911207 AND ALL RESULTS WERE FOUND TO BE WITHIN REQUIRED LIMITS. TEN RETAINED SAMPLES OF LOT 1911207 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGED OR MOLDING DEFECTS WERE OBSERVED AND SILICONE CONTENT AND BREAKOUT FORCE TESTING VERIFIED PRODUCT MET REQUIRED SPECIFICATIONS. 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 AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL CLEAR 14GA 1-1/4IN PUMP ALARMS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MISTAKE DOES NOT HAPPEN WHEN USING B. BRAUN SYRINGES. THE CUSTOMER WANTS TO RECEIVE NEW SYRINGES. THE PUMP SHOWS LOCKING ALARM AFTER 80%. BACKGROUND: THE SYRINGES ARE FILLED IN THE PHARMACY WITH OPIATES AND USED IN THE LABOR ROOM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML LL CLEAR 14GA 1-1/4IN PUMP ALARMS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MISTAKE DOES NOT HAPPEN WHEN USING B. BRAUN SYRINGES. THE CUSTOMER WANTS TO RECEIVE NEW SYRINGES. THE PUMP SHOWS LOCKING ALARM AFTER 80%. BACKGROUND: THE SYRINGES ARE FILLED IN THE PHARMACY WITH OPIATES AND USED IN THE LABOR ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71047 SYRINGE 50ML LL CLEAR 14GA 1-1/4IN SYRINGE FMF BECTON DICKINSON, S.A. 1911207

    Patients

    Seq Age Sex Outcome Treatment
    1