BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 10171753 · Received June 18, 2020

    Report

    Report Number
    1213809-2020-00403
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 22, 2020
    Report Date
    July 2, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE 1ML SYRINGE WITH UNKNOWN TIP CAP IN AN OPENED BLISTER PACK FROM BATCH 9231631 (P/N (B)(6) WAS RECEIVED AND EVALUATED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 9231631 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. IT WAS OBSERVED THE BLISTER PACK HAD ORANGE AND YELLOW STAINS AND THE SYRINGE APPEARED TO BE MANIPULATED AS THERE WAS A SMALL AMOUNT OF CLEAR LIQUID INSIDE. THE REPORTED DEFECT COULD NOT BE CONFIRMED FROM THE SAMPLE RECEIVED AS THERE WAS CLEAR INDICATIONS OF MANIPULATION. PHYSICAL UNUSED SAMPLES FROM THE SAME BATCH ARE NECESSARY FOR A MORE THOROUGH INVESTIGATION. THE REPORTED DEFECT COULD NOT BE IDENTIFIED BASED ON THE SAMPLE RECEIVED AND NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP'S PLUNGER MOVEMENT WAS STIFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TOO STIFF WHEN PULLING SYRINGE".

    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 THE BD SYRINGE LUER-LOK¿ TIP'S PLUNGER MOVEMENT WAS STIFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TOO STIFF WHEN PULLING SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635800 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 UNKNOWN 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other