BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC® GRIPPER MICRO® BLUNT CANNULA SAFETY NEEDLE

    MDR report key: 6135968 · Received November 30, 2016

    Report

    Report Number
    3012307300-2016-00397
    Event Type
    Injury
    Date Received
    November 30, 2016
    Report Date
    November 4, 2016
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K021999
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER: CUSTOMER REPORTED THE CATALOG NUMBER 21-2966-24 BUT THE REPORTED POTENTIAL LOT NUMBERS HAVE THE CATALOG NUMBER 21-2965-24. POTENTIAL LOT NUMBER: 36X922 AND 36X373. POTENTIAL EXPIRATION DATE: 08/28/2021 AND 04/28/2021. POTENTIAL DEVICE MANUFACTURING DATE: 08/22/2016 AND 04/13/2016. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DELTEC GRIPPER PLUS SAFETY NEEDLE SAFETY DEVICE DID NOT ACTIVATE, WHICH CAUSED A NEEDLESTICK TO THE NURSE. IT WAS REPORTED THAT LAB WORK WAS CONDUCTED DUE TO THE NEEDLESTICK. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785119 DELTEC® GRIPPER MICRO® BLUNT CANNULA SAFETY NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CATHETER (NON-SMITHS MEDICAL)