BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 8600365 · Received May 10, 2019

    Report

    Report Number
    9614033-2019-00148
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 9, 2019
    Report Date
    June 5, 2019
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K151766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHYSICAL SAMPLE OR PHOTOGRAPH IS RECEIVED TO EVALUATE THE REPORTED DEFECT, FOREIGN MATTER. 10 PIECES OF RETENTION SAMPLES ARE SENT TO THE QUALITY CONTROL LABORATORY FOR A VISUAL AND FUNCTIONAL EVALUATION IN ORDER TO VERIFY THE DEFECT THAT THE CLIENT REPORTS. IN THE ANALYSIS OF THE RETENTION SAMPLES, NO FOREIGN MATTER OBSERVED IN THE FLUID PATH, HOWEVER IN THE ANALYSIS OF THE SAMPLES A PARTICLE (DOT) WAS OBSERVED IN THE BASE OF THE PLUNGER BUT NOT INSIDE OF THE SYRINGE OR FLUID PATH, WHICH IS ATTRIBUTABLE TO THE INK USED IN THE CYLINDER MARKED. FURTHERMORE, THE LOT WAS INSPECTED ACCORDING TO THE CURRENT WORK INSTRUCTION WITH SATISFACTORY RESULTS FOR THE CHARACTERISTICS REQUIRED FOR ITS APPROVAL INCLUDING FUNCTIONAL TESTS. NO NON-CONFORMING PART THAT COULD BE ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CLIENT WAS PRESENTED. NO DEVIATIONS (QUALITY NOTIFICATIONS) WERE REPORTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    MATERIAL NO. 309657 BATCH NO. 8222920. IT WAS REPORTED THAT DURING USE OF THE BD LUER-LOK¿ TIP SYRINGE THE CUSTOMER SAW FINE STRING OR FIBER IN THE SYRINGE WHEN FILLING IT WITH INSULIN AND HAS ENCOUNTERED ISSUES WITH FILLING SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED FROM THE CUSTOMER: "WHEN I DREW INSULIN FROM A NEW, SEALED 3ML PENFILL CARTRIDGE ON TUESDAY, I NOTICED WHAT APPEARS TO BE A PARTICLE OF SOMETHING FLOATING IN THE INSULIN, INSIDE THE SYRINGE. SOMETIMES I AM UNABLE TO EVEN FILL THE SYRINGE, AS THE NEEDLE DOES NOT ALLOW ME TO PULL BACK THE PLUNGER ON THE SYRINGE."

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 309657, BATCH NO. 8222920. IT WAS REPORTED THAT DURING USE OF THE BD LUER-LOK¿ TIP SYRINGE THE CUSTOMER SAW FINE STRING OR FIBER IN THE SYRINGE WHEN FILLING IT WITH INSULIN AND HAS ENCOUNTERED ISSUES WITH FILLING SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED FROM THE CUSTOMER: "WHEN I DREW INSULIN FROM A NEW, SEALED 3ML PENFILL CARTRIDGE ON TUESDAY, I NOTICED WHAT APPEARS TO BE A PARTICLE OF SOMETHING FLOATING IN THE INSULIN, INSIDE THE SYRINGE. SOMETIMES I AM UNABLE TO EVEN FILL THE SYRINGE, AS THE NEEDLE DOES NOT ALLOW ME TO PULL BACK THE PLUNGER ON THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391708 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 8222920 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other