BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC® GRIPPER® NEEDLES WITHOUT Y-SITE

    MDR report key: 6609195 · Received June 2, 2017

    Report

    Report Number
    3012307300-2017-01153
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    May 7, 2017
    Report Date
    May 8, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER PROVIDED A CATALOG NUMBER OF 21-2734-24, HOWEVER, THE PROVIDED LOT NUMBER OF 36 X 1051 BELONGS TO THE CATALOG NUMBER 21-2767-24. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT, A DELTEC® GRIPPER SAFETY NEEDLE, WAS NOT RETURNED FOR INSPECTION OR EVALUATION. INSTEAD, ONE PHOTO WAS RETURNED. FROM THE PHOTO, IT CAN BE OBSERVED A GRIPPER PRODUCT IN USED CONDITIONS WITH THE NEEDLE OUT OF THE BASE. RELEVANT ASSEMBLY OPERATIONS WERE REVIEWED AND CONSIDERED ADEQUATE AND CORRECT. RELEVANT MANUFACTURING AND QUALITY INSPECTION PROCESSES WERE REVIEWED AND CONSIDERED ADEQUATE AND CORRECT. A SAMPLE OF (B)(4) UNITS WERE TAKEN FROM PRODUCTION FLOOR INVENTORY TO VISUALLY INSPECT FOR ANY DAMAGES IN THE BASE. NO DISCREPANCIES WERE FOUND IN THE SAMPLES. A SAMPLE OF (B)(4) UNITS WERE TAKEN FROM INVENTORY AND WERE TESTED FOR HINGE ACTIVATION. NO DISCREPANCIES WERE DETECTED. TWO UNITS WERE TAKEN FROM THE MANUFACTURING PROCESS FOR DESTRUCTIVE TESTING. THE AY BASE WAS MANIPULATED AND EXCESSIVE FORCE WAS APPLIED WHEN ACTIVATING THE SAFETY MECHANISM. THE RESULTS SHOWED THAT THE NEEDLE WENT PAST THE SAFETY MECHANISM AND WAS LEFT EXPOSED. THE INSTRUCTIONS FOR USE WAS REVIEWED WHERE A NOTE OF WARNING DESCRIBES THE CARE THAT MUST BE TAKEN WHEN USING THE PRODUCT. THE ROOT CAUSE IS UNKNOWN. THE MOST PROBABLE ROOT CAUSE IS THAT THE DAMAGE TO THE SAFETY ARM OCCURRED AFTER THE PRODUCT LEFT THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN WITHDRAWING A DELTEC® GRIPPER® NEEDLES WITHOUT Y-SITE FROM A PATIENT, THE SAFETY DEVICE "DID NOT WORK" AND THE NEEDLE PUNCTURED THE NURSE'S FINGER. THE NURSE WAS WEARING GLOVES AND AN IMPERMEABLE APRON AS PER THE SAFETY INSTRUCTIONS FOR WITHDRAWAL OF CHEMOTHERAPY INFUSION SETS. A SEROLOGY WAS DONE ON THE PATIENT AND NURSE FOR ANALYSIS. NO PERMANENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE PATIENT WAS NOT INJURED DURING THE EVENT. THE NECESSARY EXAMINATION WAS PERFORMED AND NO PERMANENT DAMAGE WAS IDENTIFIED. THE EVENT WAS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389000 DELTEC® GRIPPER® NEEDLES WITHOUT Y-SITE SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 36X1051

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other