BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PLASTIPAK 50ML LUER LOCK SYRINGE

    MDR report key: 3800211 · Received April 29, 2014

    Report

    Report Number
    2243072-2014-00084
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BD
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: NO SAMPLES WERE REC'D FOR EVALUATION. CONCLUSIONS: DUE TO SIMILAR COMPLAINTS FOR THE 50ML SYRINGE, IMPLEMENTATION OF A HIGHER VISCOSITY BARREL LUBE WAS PERFORMED AT THE PLANT, WHICH HAD SHOWN TO LOWER PUMP FORCES. IN ADDITION, AN IN-PROCESS PUMP FORCE REQUIREMENT HAS BEEN IMPLEMENTED. NEW LUBRICATION HAS BEEN IMPLEMENTED AT THE BEGINNING OF (B)(6) 2014.

    Description of Event or Problem · 1

    AN ICU PATIENT WAS RECEIVING MANUALLY DRAWN NORADRENALINE INFUSION VIA AN ALARIS PUMP. THE OCCLUSION ALARM TRIGGERED, THE PUMP FAILED TO DELIVER, AND THE PATIENT REQUIRED RESUSCITATION. A GEMINI PUMP ALSO FAILED IN THIS INSTANCE. A 30ML SYRINGE WAS USED WITHOUT PROBLEMS. THE FACILITY HAS CHECKED THE PUMPS AND CONFIRMED THEY ARE IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256477 BD PLASTIPAK 50ML LUER LOCK SYRINGE 50ML LUER LOCK SYRINGE FMF BD 1310200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention