BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8918295 · Received August 21, 2019

    Report

    Report Number
    1710034-2019-00914
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    July 31, 2019
    Report Date
    September 6, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825333
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLE, BATCH, OR LOT CODE WAS PROVIDED. THIS COMPLAINT WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED & TRENDED FOR FUTURE OCCURRENCES. THE COMPLAINT WAS DEEMED AS MDR REPORTABLE THEREFORE A SUBMISSION WILL BE PERFORMED. SHALL A SAMPLE OR LOT NUMBER BECOME AVAILABLE, THE COMPLAINT WILL BE RE-OPENED AND AN INVESTIGATION WILL TAKE PLACE. THIS COMPLAINT WILL BE CLOSED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HELLO, I HOPE THIS EMAIL FINDS YOU WELL. I'M EMAILING AS THE JSC RN'S HAVE FOUND THAT ON MULTIPLE OCCASIONS WE HAVE FOUND THE IV CATHETERS HAVE LEAKED IMMEDIATELY AFTER RELEASING THE TOURNIQUET (CAUSING A BIG MESS). THE FEATURE SEEMS TO BE FAILING. IT HAPPENED FREQUENTLY A FEW MONTHS BACK BUT THEN HAPPENED TODAY. THE LOT # TODAY WAS 8310640. AS IT SEEMED TO BE RANDOM IN THE PAST, WE DIDN'T TRACK THE LOT NUMBERS. I'M NOT SURE IF ANYONE IN THE HOSPITAL HAS MENTIONED THIS OR IF I SHOULD LET SOMEONE ELSE KNOW. I SAVE THE WRAPPER FROM TODAY'S EVENT." 1 OF 3 COMPLAINTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 LEAKAGE OCCURRED DURING USE WITH BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HELLO, I HOPE THIS EMAIL FINDS YOU WELL. I'M EMAILING AS THE JSC RN'S HAVE FOUND THAT ON MULTIPLE OCCASIONS WE HAVE FOUND THE IV CATHETERS HAVE LEAKED IMMEDIATELY AFTER RELEASING THE TOURNIQUET (CAUSING A BIG MESS). THE FEATURE SEEMS TO BE FAILING. IT HAPPENED FREQUENTLY A FEW MONTHS BACK BUT THEN HAPPENED TODAY. THE LOT # TODAY WAS 8310640. AS IT SEEMED TO BE RANDOM IN THE PAST, WE DIDN'T TRACK THE LOT NUMBERS. I'M NOT SURE IF ANYONE IN THE HOSPITAL HAS MENTIONED THIS OR IF I SHOULD LET SOMEONE ELSE KNOW. I SAVE THE WRAPPER FROM TODAY'S EVENT." 1 OF 3 COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712738 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other