BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL

    MDR report key: 12014290 · Received June 17, 2021

    Report

    Report Number
    1213809-2021-00429
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    March 18, 2021
    Report Date
    June 8, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THREE PHOTOS WERE RECEIVED. EACH PHOTO WAS VISUALLY EVALUATED. ONE PHOTO SHOWED A PORTION OF A 1ML LUER LOCK SYRINGE (P/N 309628) WITH A CUSTOMER ATTACHED NEEDLE THAT WAS FILLED WITH MEDICATION. JUST ABOVE THE STOPPER AN AREA WAS CIRCLED IN RED MARKER THAT APPEARED TO SHOW A FIBROUS STRAND OF FOREIGN MATTER OUTSIDE OF THE FLUID PATH LARGER THAN LEVEL 3 IN SIZE. THE STRAND OF FM APPEARED TO BE A HAIR. ONE PHOTO SHOWED A FIBROUS STAND OF FOREIGN MATTER INSIDE A PETRI DISH THAT APPEARED TO BE A HAIR. ONE PHOTO SHOWED WHAT APPEARED TO BE A MAGNIFIED PHOTO OF THE STRAND OF HAIR THAT WAS OBSERVED IN THE SYRINGE AND PETRI DISH. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER (HAIR) DEFECT IS ASSOCIATED WITH THE MATERIAL HANDLING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH #9092983 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 1ML LL HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE REPORTER STATED THAT AFTER THE DOSE WAS DRAWN UP INTO A SYRINGE, THE OPERATOR NOTICED THAT A HAIR LIKE PARTICLE WAS INSIDE THE SYRINGE. AS A RESULT, THE DOSE WAS NOT USED. THE REPORTER DENIED ANY ADVERSE EVENT OR MISSED DOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916026 SYRINGE 1ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9092983 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1