BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAVEN 22G 25MM

    MDR report key: 9186307 · Received October 14, 2019

    Report

    Report Number
    3006846316-2019-00001
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    June 4, 2019
    Report Date
    October 11, 2019
    Manufacturer
    DELTA MED SPA
    Product Code
    FOZ
    PMA / PMN Number
    K171530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MALFUNCTION COMPLAINED WAS RELATED TO THE NEEDLE SHIELD THAT DID NOT ENGAGE AND DID NOT COVER THE TIP OF THE NEEDLE. (REF. REPORT MW5087281). AS THE DEVICE INVOLVED IN THE MALFUNCTION REPORTED WAS NOT AVAILABLE FOR DELTA MED EVALUATION, THE INVESTIGATION WAS PERFORMED BASING ON THE REVIEW OF THE BATCH RECORD AND THE TEST ON THE STERILE RETAINED SAMPLES AS FOLLOWING DESCRIBED. REVIEW OF THE BATCH RECORD DATA OF THE LOT INVOLVED IN THE EVENT WITH SPECIAL REGARD TO THE RESULTS OBTAINED AT THE ACTIVATION OF THE NEEDLE SHIELD TEST PERFORMED BY THE CONTRACT MANUFACTURER. THE RESULTS OBTAINED WERE WITHIN THE LIMITS DEFINED FOR THIS CONTROL. TO PRODUCE THE LOT N° 1170529, WAS USED THE SEMIFINISHED DEVICE IDENTIFIED WITH THE LOT N° 0000070514. THE PRODUCTION OF LOT 0000070514 TOOK PLACE FROM 29-NOVEMBER -2017 UP TO 01-DECEMBER 2017 AND DURING THIS DATES N° 40 PIECES WERE TESTED AT THE ACTIVATION OF THE NEEDLE SHIELD TEST. ALL THE RESULTS WERE WITHIN THE LIMITS. THE EVIDENCES OF THE RESULTS OBTAINED ARE AVAILABLE IN ANNEX A TOGETHER WITH THE TRANSLATION OF THE DOCUMENTATION. N°5 STERILE RETAINED SAMPLES OF THE SAME LOT WERE SUBMITTED TO THE NEEDLE SHIELD ACTIVATION TEST BY THE CONTRACT MANUFACTURER. THE RESULTS OBTAINED WERE WITHIN THE LIMITS DEFINED FOR THIS CONTROL. IN ANNEX B ARE AVAILABLE THE COPY OF THE REPORT TEST IN THE ORIGINAL FORMAT AND TRANSLATED. BY THE REVIEW OF THE BATCH RECORD DATA AND FROM THE RESULTS OBTAINED TESTING THE RETAINED SAMPLES THERE WERE NO DEVIATIONS IN THE LOT PERFORMANCES THAT COULD LEAD TO FIND A POSSIBLE MALFUNCTION OF THE DEVICES. REPORT LATE DUE TO TRANSITION FROM VMSR PROGRAM.

    Description of Event or Problem · 1

    AS REPORTED IN THE REPORT MW5087281 RECEIVED BY OUR US AGENT (B)(6) ON 06.25.2019: STAFF WERE PLACING AN IV CATHETER IN THIS PATIENT. THE STYLET WAS REMOVED, BUT THE NEEDLE SHIELD DID NOT ENGAGE AND COVER THE TIP OF THE NEEDLE. FDA SAFETY REPORT ID#(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983513 DELTAVEN 22G 25MM INTRAVASCULAR CATHETER FOZ DELTA MED SPA 3825272 11T70529

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR