BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 8125131 · Received December 3, 2018

    Report

    Report Number
    3002682307-2018-00296
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 16, 2018
    Report Date
    January 3, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLES. COMPLAINT TRENDING REVIEW OF THIS LOT AND DEFECT REVEALS NO MORE COMPLAINTS. NO TREND IS OBSERVED FOR THIS DEFECT ON THE REPORTED PRODUCT FAMILY. DHR REVIEW FOR LOT # 1801276: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2023 (JANUARY 17TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4253, Nº4235, Nº4213, Nº4212, AND Nº4203, IN LOT #8022705 (JANUARY 22ND ¿ 29TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8022719, #8015780, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8022723, #8015644, AND #7354665 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. DHR REVIEW FOR LOT # 1805305: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2028 (MAY 30TH ¿ 31ST, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4253, Nº4235, Nº4213, Nº4212, AND Nº4203, IN LOT #8148566 (MAY 28TH ¿ JUNE 4TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8149704, #8142762, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8149708, #8142766, #8135536 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. INVESTIGATION CONCLUSION: AFTER THE EVALUATION OF THE RETURNED SAMPLES, WE CONFIRMED THE REPORTED ISSUE, AND CONCLUDED THAT THE WHITE PARTICLES INSIDE THE SYRINGE WERE COMPOSED BY LUBRICANT FROM THE SYRINGE BARREL. ROOT CAUSE DESCRIPTION: PARTICLES COMPOSED BY LUBRICANT, WHICH IS INCLUDED IN THE PLASTIC FORMULATION AND IT IS INHERENT TO THE DESIGN AND FUNCTION OF 2 PIECE SYRINGES. RATIONALE: WE HAVE INITIATED THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS FOR THIS ISSUE. CAPA #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD DISCARDIT¿ II SYRINGE HAD FOREIGN MATTER IN THE SYRINGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1801276, EXPIRATION DATE: 2022-12-31, MANUFACTURE DATE: 2018-01-26. MEDICAL DEVICE LOT #: 1805305, EXPIRATION DATE: 2023-04-30, MANUFACTURE DATE: 2018-05-22. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD DISCARDIT¿ II SYRINGE HAD FOREIGN MATTER IN THE SYRINGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965038 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other