BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8967464 · Received September 5, 2019

    Report

    Report Number
    2243072-2019-01927
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    August 9, 2019
    Report Date
    October 9, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE CATALOG AND LOT NUMBERS HAVE BEEN UPDATED. THE FOLLOWING INFORMATION HAS BEEN CORRECTED: B.4. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE EXTENSION SET LEAKED FROM THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER CONNECTION SITE DURING USE. LOTS 9128619 AND 9122769 WERE REPORTED TO HAVE 1 OCCURRENCE EACH OF THE EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO NURSES FOR THE EXTENSION SET LEAKING AT THE SITE WHERE IT ATTACHES TO THE IV CATHETER. 2 CASES NOTED. D.1. MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. D.2. MEDICAL DEVICE CATALOG#: 381412. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 9128619 D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30 H.4. DEVICE MANUFACTURE DATE: 2019-05-08 D.4. MEDICAL DEVICE LOT #: 9122769 D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30 H.4. DEVICE MANUFACTURE DATE: 2019-05-02 D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2. MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. G.5. PMA / 510(K)#: K952861 H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXTENSION SET LEAKED FROM THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER CONNECTION SITE DURING USE. LOTS: 9128619 AND 9122769 WERE REPORTED TO HAVE 1 OCCURRENCE EACH OF THE EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO NURSES FOR THE EXTENSION SET LEAKING AT THE SITE WHERE IT ATTACHES TO THE IV CATHETER. 2 CASES NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXTENSION SET LEAKED FROM THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER CONNECTION SITE DURING USE. LOTS 9128619 AND 9122769 WERE REPORTED TO HAVE 1 OCCURRENCE EACH OF THE EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO NURSES FOR THE EXTENSION SET LEAKING AT THE SITE WHERE IT ATTACHES TO THE IV CATHETER. 2 CASES NOTED.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 EXTENSION SET LEAKED FROM THE UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ IV CATHETER CONNECTION SITE DURING USE. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO NURSES FOR THE EXTENSION SET LEAKING AT THE SITE WHERE IT ATTACHES TO THE IV CATHETER. 2 CASES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761505 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other