BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8199374 · Received December 27, 2018

    Report

    Report Number
    1710034-2018-00961
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    December 12, 2018
    Report Date
    February 15, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR AND SAP (QN) DATABASE REVIEWS; WERE NOT CONDUCTED BECAUSE A LOT NUMBER WAS NOT PROVIDED. UNIT: RECEIVED ONE 20GA BD INSYTE AUTOGUARD IV CATHETER UNIT WITHOUT PACKAGING. ALL COMPONENTS WERE PRESENT AND INTACT. PHOTO: ONE PHOTO WAS PROVIDED FOR EVALUATION OF THIS INCIDENT WHICH REVEALED A 20GA CATHETER/ADAPTER ASSEMBLY OVER THE NEEDLE. THE PHOTO SHOWN THE CATHETER TUBING TO HAVE FOREIGN MATTER PRESENT NEAR THE TIP. UNIT: VISUAL OBSERVATION REVEALED THERE WAS FIBER (FM) PRESENT BELOW THE AREA OF THE TIP OF THE CATHETER TUBING. MICROSCOPIC EVALUATION CONFIRMED THE FM WAS IDENTIFIED TO BE AS A GRAY FIBER. NO OTHER DAMAGE WAS OBSERVED. PHOTOS: THE FOREIGN MATTER (GRAY FIBER) SEEN ON THE RETURNED UNIT WAS ALSO SEEN IN THE PROVIDED PHOTO. CONFIRMATION OF THE DEFECT OF FOREIGN MATTER, WAS CONCLUSIVE BASED ON THE OBSERVATIONS OF THE UNIT AND PHOTO PROVIDED FOR THIS INCIDENT. CONCLUSION(S): RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE - BASED ON THE CHARACTERISTICS OF THE FM (FIBER), IT IS UNKNOWN HOW OR WHEN THE FOREIGN MATTER/FIBER WAS INTRODUCED TO THE CATHETER, AS THE UNIT WAS RECEIVED OUT OF PACKAGING. THERE WAS NO EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: D.2. MEDICAL DEVICE TYPE: FOZ G.5. PMA/510(K)#: K952861.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD FOREIGN MATTER ON THE CATHETER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD FOREIGN MATTER ON THE CATHETER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD FOREIGN MATTER ON THE CATHETER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037796 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVENOUS CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other