BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8506338 · Received April 11, 2019

    Report

    Report Number
    1710034-2019-00403
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 27, 2019
    Report Date
    May 30, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825340
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS HAD DULL NEEDLES, AND THE HUB DOES NOT CONNECT WELL TO THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO.: 382534 BATCH NO.: 9031872 AND 9021605. IT WAS REPORTED THAT THE NEEDLES ARE DULL AND THE HUB DOES NOT CONNECT WELL TO THE TUBING. PER EMAIL: HI THERE, WE HAVE BEEN RUNNING INTO "BAD" 20 GAUGE ANGIOS. THE NURSES ARE REPORTING THAT THE NEEDLES ARE DULL AND THE HUB DOESN'T CONNECT AS WELL TO THE IV TUBING. HERE ARE TWO LOTS FROM THIS MORNING WITH THESE ISSUES 9031872 AND 9021605 (20 GA X 1.16 IN)."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9031872; MEDICAL DEVICE EXPIRATION DATE: 2022-01-31; DEVICE MANUFACTURE DATE: 2019-01-31; MEDICAL DEVICE LOT #: 9021605; MEDICAL DEVICE EXPIRATION DATE: 2021-12-31; DEVICE MANUFACTURE DATE: 2019-01-21. 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 INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS HAD DULL NEEDLES, AND THE HUB DOES NOT CONNECT WELL TO THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO.: 382534, BATCH NO.: 9031872 AND 9021605. IT WAS REPORTED THAT THE NEEDLES ARE DULL AND THE HUB DOES NOT CONNECT WELL TO THE TUBING. PER EMAIL: HI THERE, WE HAVE BEEN RUNNING INTO "BAD" 20 GAUGE ANGIOS. THE NURSES ARE REPORTING THAT THE NEEDLES ARE DULL AND THE HUB DOESN'T CONNECT AS WELL TO THE IV TUBING. HERE ARE TWO LOTS FROM THIS MORNING WITH THESE ISSUES 9031872 AND 9021605 (20 GA X 1.16 IN)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297755 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 30382903825340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other