BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PLASTIPAK 50 ML LUER LOCK SYRINGE

    MDR report key: 3802857 · Received May 1, 2014

    Report

    Report Number
    2243072-2014-00088
    Event Type
    Injury
    Date Received
    May 1, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BD
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS:L NO SAMPLES ARE AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCLUSION: 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 FEBRUARY 2014. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS BEING OPERATED ON FOR NEUROSURGERY LESION WITH OPEN SKULL. THE SYRINGE PUMP ALARM SOUNDED FOR OCCLUSION AND THE SYRINGE WAS CHANGED. THE PATIENT WOKE UP ON THE TABLE AND BECAME AGITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261141 BD PLASTIPAK 50 ML LUER LOCK SYRINGE 50ML LUER LOCK SYRINGE FMF BD 1401310

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention