BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 20ML SYRINGE LUER-LOK

    MDR report key: 10251904 · Received July 9, 2020

    Report

    Report Number
    3003152976-2020-00298
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 22, 2020
    Report Date
    August 7, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6)2020. H.6. INVESTIGATION: SIX UNUSED SAMPLES OF LOT 2002219, 2002251, AND LOT 2002300 WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, IT COULD NOT BE OBSERVED THAT THE SCALE WAS INCORRECTLY PLACED ON ANY OF THE SYRINGES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 1912272, 2002219, 2002300 AND 2002251, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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. DURING THE BARREL PRINTING PROCESS, OPERATORS PERIODICALLY VERIFY THE VOLUME ACCURACY WITH A PASS/NON PASS GAUGE. THE EIGHTEEN RETURNED SAMPLES WERE EVALUATED USING THE SAME METHOD AND WERE FOUND TO BE WITHIN REQUIRED TOLERANCE. SCALE PRECISION AND DIED SPACE IS ALSO INSPECTED DURING MANUFACTURING AND ALL RETURNED SAMPLES WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿ HAD A VOLUMETRIC ACCURACY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CLIENT CLAIMS A POTENTIAL DYSFUNCTION OF THE SYRINGE SCALE. THE PROBLEM WAS DETECTED WHEN LOADING ACYCLOVIR VIALS. WHEN A VOLUME OF 20 ML OF ACYCLOVIR WAS LOADED, FIRST WITH 2 SYRINGES OF 10 ML AND THEN WITH 50 ML SYRINGES, THE ENTIRE VIAL WAS FILLED. ON THE CONTRARY, WHEN LOADING WITH 20 ML SYRINGES, THERE IS A REMAINING VOLUME. THE TEST WAS CARRIED OUT WITH SEVERAL BATCHES OF 20 ML SYRINGES TO VERIFY THAT IT WAS NOT A SPECIFIC BATCH. THE SAME INCIDENT HAPPENED IN ALL THE BATCHES OF SYRINGES 20 ML.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1912272, MEDICAL DEVICE EXPIRATION DATE: 2024-11-30, DEVICE MANUFACTURE DATE: 2019-12-12, MEDICAL DEVICE LOT #: 2002219, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2020-02-06, MEDICAL DEVICE LOT #: 2002300, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2020-02-27. MEDICAL DEVICE LOT #: 2002251, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2020-02-14. 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 BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿ HAD A VOLUMETRIC ACCURACY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CLIENT CLAIMS A POTENTIAL DYSFUNCTION OF THE SYRINGE SCALE. THE PROBLEM WAS DETECTED WHEN LOADING ACYCLOVIR VIALS. WHEN A VOLUME OF 20 ML OF ACYCLOVIR WAS LOADED, FIRST WITH 2 SYRINGES OF 10 ML AND THEN WITH 50 ML SYRINGES, THE ENTIRE VIAL WAS FILLED. ON THE CONTRARY, WHEN LOADING WITH 20 ML SYRINGES, THERE IS A REMAINING VOLUME. THE TEST WAS CARRIED OUT WITH SEVERAL BATCHES OF 20 ML SYRINGES TO VERIFY THAT IT WAS NOT A SPECIFIC BATCH. THE SAME INCIDENT HAPPENED IN ALL THE BATCHES OF SYRINGES 20 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719827 BD PLASTIPAK 20ML SYRINGE LUER-LOK SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other