BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC® GRIPPER PLUS® SAFETY NEEDLE

    MDR report key: 7309636 · Received March 2, 2018

    Report

    Report Number
    3012307300-2018-00455
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    August 14, 2017
    Report Date
    July 10, 2018
    Manufacturer
    SMITHS MEDICAL, ASD, INC.
    Product Code
    FPA
    UDI-DI
    30610586028391
    PMA / PMN Number
    K042172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CUSTOMER'S RETURNED SAMPLE WAS RECEIVED IN UNUSED CONDITION WITHIN ITS ORIGINAL PACKAGING. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12" TO 24" UNDER NORMAL CONDITIONS OF ILLUMINATION AND NO DISCREPANCIES WERE DETECTED. A FUNCTIONAL TEST OF THE SAMPLE REVEALED THE SAFETY MECHANISM WAS ACTIVATED AND PERFORMING AS INTENDED. A REVIEW OF THE MANUFACTURING PROCESS FOR P/N 21-2767-24 L/N 3644120 WAS CONDUCTED IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT DESCRIBED BY THE CUSTOMER. PRODUCTION PERSONNEL ARE CERTIFIED TO PERFORM A FUNCTIONAL TEST USING THE INSERTION PAD FIXTURE T98-5406, IN ORDER TO INSPECT IF THE NEEDLE IS RETRACTED. PRODUCTION PERSONNEL TAKE A SAMPLE OF FOUR AT START UP, THE BEGINNING OF EVERY JOB AND AT LEAST EVERY THREE HOURS, IN ORDER TO IDENTIFY ANY ABNORMAL BEHAVIOR ON THE TRANSFER OF THE SITE TO THE PAD. QUALITY PERSONNEL VERIFIES THAT DEVICE DID NOT TRIGGER DURING CAPPING. NO ROOT CAUSE HAS BEEN DETERMINED SINCE THE COMPLAINT WAS NOT CONFIRMED. SMITHS MEDICAL REGULARLY ANALYZES COMPLAINT DATA AND TRENDS, AND WILL TAKE FURTHER ACTIONS ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A NURSE REMOVED THE HUBER NEEDLE (DELTEC® GRIPPER PLUS® SAFETY NEEDLE) AT THE END OF TREATMENT, THE SAFETY MECHANISM DID NOT LOCK. THERE WAS NO PATIENT OR CLINICIAN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154366 DELTEC® GRIPPER PLUS® SAFETY NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL, ASD, INC. 37X605 30610586028391

    Patients

    Seq Age Sex Outcome Treatment
    1