BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

    MDR report key: 6764293 · Received August 3, 2017

    Report

    Report Number
    1213809-2017-00062
    Event Type
    Malfunction
    Date Received
    August 3, 2017
    Date of Event
    July 13, 2017
    Report Date
    October 4, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SIX 3ML SYRINGES IN THEIR ORIGINAL SEALED PACKAGING WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH #7031978 (P/N (B)(4)). THEY WERE VISUALLY EVALUATED. ALL SIX SYRINGES EXHIBITED VARYING DEGREES OF THE SAME TYPE OF PRINT DEFECTS: SEVERE INK RINGS AND MISSING PRINT WERE FOUND ON EACH ONE. NO FOREIGN MATTER WAS FOUND IN ANY OF THE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. THERE WAS A RECORDED INSTANCE OF ISSUES WITH THE MARKER THAT CAUSED INK RINGS. BATCH 7031978 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ROOT CAUSE: CLOGGED MANIFOLD. A CLOGGED MANIFOLD RESULTS IN INCONSISTENT INK FLOW TO THE PRINTING CYLINDER SURFACE, CAUSING INK RINGS AND MISSING PRINT. CORRECTIVE ACTIONS: ACTIONS WERE TAKEN AT THE TIME THE DEFECT WAS DISCOVERED. MANIFOLD WAS CLEANED AND DOCTOR BLADE REPLACED BEFORE PRODUCTION RESUMED.

    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 BLACK MARKS WERE FOUND INSIDE A BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543349 BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other