BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1213809-2019-00370

    MDR report key: 8440511 · Received March 21, 2019

    Report

    Report Number
    1213809-2019-00370
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    February 22, 2019
    Report Date
    March 27, 2019
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS A DUPLICATE OF MFR REPORT # 1213809-2019-00314. PLEASE CONSIDER THIS MDR CANCELLED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS A DUPLICATE OF MFR REPORT # 1213809-2019-00314. PLEASE CONSIDER THIS MDR CANCELLED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD MISSING SCALE MARKINGS. THE FOLLOWING WAS REPORTED. "MATERIAL NO.: 309657. BATCH/LOT: 8213794. IT WAS REPORTED THAT THIS PRODUCT IS MISSING SCALE MARKINGS. CUSTOMER TEXT: WHILE SEARCHING FOR AFFECTED PRODUCT IN OUR INVENTORY, WE CAME ACROSS AN AFFECTED ITEM THAT WAS NOT LISTED IN YOUR ORIGINAL RECALL NOTIFICATION. LOT NUMBER 8213794 FOR 309657 IS ALSO MISSING SCALE MARKINGS."

    Patients

    Seq Age Sex Outcome Treatment
    1 Other