BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 10805128 · Received November 6, 2020

    Report

    Report Number
    1213809-2020-00780
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 13, 2020
    Report Date
    March 15, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 0041190. D.4. MEDICAL DEVICE EXPIRATION DATE: 11/30/2024. H.4. DEVICE MANUFACTURE DATE: 3/11/2020. D.4. MEDICAL DEVICE LOT #: 0038923. D.4. MEDICAL DEVICE EXPIRATION DATE: 11/30/2024. H.4. DEVICE MANUFACTURE DATE: 4/16/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED POTENTIAL FINAL LOT NUMBERS 0041190 AND 0038923 AND ALL APPLICABLE SUB-ASSEMBLY LOT NUMBERS. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, FIVE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, FOREIGN MATTER WAS IDENTIFIED. SMALL BLACK SPECKS OF FOREIGN MATTER WERE OBSERVED OUTSIDE OF THE PLUNGER RODS RETAINING RING AND INSIDE OF THE BARREL FLANGE WHERE THE TWO SURFACES TOUCHED. THE FOREIGN MATTER WAS OUTSIDE OF THE FLUID PATHWAY AND APPEARED TO BE LOOSE. AT THIS TIME, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE IDENTIFIED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON 5 BD LUER-LOK¿ SYRINGES' PLUNGER RODS AND BARRELS IN THE BULK STERILE PHARMACY CONVENIENCE TRAYS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLACK AMORPHOUS AND LIGHT/FLAKEY REMOVABLE MATERIAL OBSERVED ON SYRINGE SURFACE, PLUNGER ROD AND BARREL."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON 5 BD LUER-LOK¿ SYRINGES' PLUNGER RODS AND BARRELS IN THE BULK STERILE PHARMACY CONVENIENCE TRAYS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLACK AMORPHOUS AND LIGHT/FLAKEY REMOVABLE MATERIAL OBSERVED ON SYRINGE SURFACE, PLUNGER ROD AND BARREL.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262846 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309703 SEE H.10 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1