BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 5006607 · Received August 11, 2015

    Report

    Report Number
    0001710034-2015-00005
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    July 20, 2015
    Report Date
    August 11, 2015
    Manufacturer
    BD
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: TWO UNUSED SAMPLES, ONE FROM LOT NUMBER 4300687 AND ONE FROM LOT NUMBER 4240987, WERE RECEIVED FOR EVAL. A VISUAL/MICROSCOPIC ANALYSIS OF BOTH UNITS REVEALED THE BEVEL AREA HAD THE PROPER BEVEL CUT AND THE SECONDARY BEVEL WAS PRESENT. LIE DISTANCE WAS WITHIN THE ACCEPTABLE RANGE OF .001 - 0.023 INCHES. THE NEEDLES WERE NOT BENT OR PINCHED AND THERE WAS NO GRIPPER DAMAGE TO THE NEEDLES. A PACKAGE LEAK TEST WAS PERFORMED FOR BOTH UNITS AND NO LEAKS OR OPENED SEALS WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 4300687 REVEALED NO IRREGULARITIES DURING THE MFR OF THE REPORTED LOT NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 4240987 REVEALED A QUALITY NOTIFICATION FOR TIP QUALITY THAT COULD BE ASSOCIATED WITH THIS INCIDENT HOWEVER THE QUALITY NOTIFICATION REVIEW FOR BOTH LOT NUMBERS REVEALED NO RELATED REJECT ACTIVITY FOR EITHER LOT NUMBER. STERILITY RECORDS (PYROGEN TESTING) FOR BOTH LOT NUMBERS WERE REVIEWED AND THE PYROGEN SAMPLES PASSED ALL TESTING. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE CONFIRMED AS THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD INSYTE AUTOGUARD SHIELDED IV CATHETER A PT DEVELOPED AN ABSCESS AT THE IV INSERTION SITE. THE PT RECEIVED TREATMENT FOR HIS/HER ABSCESS, HOWEVER THE CUSTOMER IS UNABLE TO PROVIDE ANY DETAILS REGARDING THE SPECIFIC TREATMENT THE PT RECEIVED. OF NOTE, THE REPORTING FACILITY COULD NOT CONFIRM A LOT NUMBER FOR THIS INCIDENT BUT SUSPECTS THAT IT WAS EITHER LOT NUMBER 4300687 OR 4240987. BELOW ARE THE EXPIRATION DATES AND DEVICE MFR DATE FOR EACH LOT NUMBER: 4300687: EXP DATE: 10/31/2017, DEVICE MFR DATE: OCTOBER 2014; 4240987: EXP DATE: 09/30/2017, DEVICE MFR DATE: AUGUST 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526713 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention