BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50ML LL PRECISE

    MDR report key: 10112926 · Received June 2, 2020

    Report

    Report Number
    2243072-2020-00871
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    May 14, 2020
    Report Date
    May 18, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE LOT #: 1912254 WAS REPORTED, HOWEVER, THIS IS NOT A MANUFACTURED LOT# FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: TWO PHOTOS AND THREE SAMPLES WERE RECEIVED BY OUR QUALITY ENGINEER TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE SAMPLES AND PHOTOS, FOREIGN MATTER WAS OBSERVED INSIDE THE BARREL. FURTHER INSPECTION DETERMINED THE PARTICLES CONSISTED OF POLYPROPYLENE FIBERS WITH SILICONE AND GREASE MIXED IN. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1912254, NO DEVIATIONS OR NON-CONFORMANCE'S RELATED TO THE REPORTED ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. IT IS LIKELY THE POLYPROPYLENE ORIGINATED FROM THE ASSEMBLY STATION WHILE THE PROCESS OF LUBRICATING THE BARREL TOOK PLACE. MACHINES ROUTINELY UNDERGO PROPER MAINTENANCE AND CLEANING. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE. RATIONALE: BASED ON QDA LIMITS FOR THIS PRODUCT AND DEFECT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED FOREIGN MATTER WAS DISCOVERED ON PLUNGER DURING USE WITH A BD SYRINGE 50ML LL PRECISE¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS COLORED PARTICLES ON THE SYRINGE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571656 BD SYRINGE 50ML LL PRECISE PISTON SYRINGE FMF BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other