BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8663846 · Received June 3, 2019

    Report

    Report Number
    1710034-2019-00585
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 16, 2019
    Report Date
    June 27, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON THE REPORTED LOT NUMBER 8253952; THE LOT NUMBER WAS BUILT ON AFA LINE 2 FROM 13SEPT18 THRU 19SEPT18. PACKAGED ON PACKAGING LINE 8 FROM 15SEPT18 THRU 18SEPT18 AND PACKAGING LINE 9 FROM 18SEPT18 THRU 19SEPT18 FOR A QUANTITY OF (B)(4) UNITS. NO REJECT ACTIVITY ASSOCIATED WITH THE LOT NUMBER PROVIDED WAS FOUND. NO TESTING OR OBSERVATIONS COULD BE PERFORMED AS NO UNITS WERE RETURNED FOR EVALUATION. CONCLUSION(S): THE DEFECT DESCRIBED IN THE PRODUCT INCIDENT REPORT WAS NOT IDENTIFIED OR CONFIRMED; AS UNITS OR PHOTOS WERE NOT PROVIDED FOR THIS INCIDENT, THEREFORE A DEFINITE ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE DIDN'T FULLY RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE DIDN¿T FULLY RETRACT"

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT #: [8252Q52] WAS NOT FOUND FOR THE REPORTED CATALOG #: [381423]. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE DIDN'T FULLY RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE DIDN¿T FULLY RETRACT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458480 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Other