BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8004712 · Received October 25, 2018

    Report

    Report Number
    1710034-2018-00758
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    October 4, 2018
    Report Date
    January 8, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814337
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MEDWATCH DETAIL REPORT # MW5080413.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON LOT NUMBER: 8130949; THE LOT NUMBER WAS BUILT ON AFA LINE 6 FROM 18MAY2018 THRU 24MAYL2018. PACKAGED ON PACKAGING LINE 9 FROM (B)(6) 2018 THRU (B)(6) 2018. REVIEW OF THE DHR¿S REVEALED THAT ALL CHALLENGE, SET-UP AND IN-PROCESS SAMPLES WERE PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. RECEIVED ONE USED IAG 20 G CATHETER/ADAPTER ASSEMBLY FROM CATALOG NUMBER: 381433, UNKNOWN LOT NUMBER WITH AN EXTENSION SET. ALSO RECEIVED ONE UNUSED IAG 20GA UNIT IN A SEALED PACKAGE FROM CATALOG NUMBER: 381433, LOT NUMBER: 8130949. VISUAL/MICROSCOPIC EVALUATION: USED: THERE WAS TUBING WAS MISSING FROM THE ADAPTER WITH RESIDUAL TUBING ATTACHED TO THE WEDGE. THE REST OF THE SAMPLE (TUBING) WAS NOT RETURN FOR EVALUATION. THE SEPARATION SITE HAS SMOOTH EDGES AND JAGGED EDGES ALONG THE ENTIRE CIRCUMFERENCE SHOWING NO EVIDENCE OF A PUNCTURE WHICH INDICATES THAT THE CATHETER BROKE OFF AS A RESULT OF EXCESSIVE TENSILE PULLING. THE SURFACE OF THE SEPARATION SITE WAS SMOOTH UNUSED: NO SIGNS OF BENDS, CUTS, HOLES, KINKS, SPLITS, OR WRINKLES WERE FOUND IN THE CATHETER TUBING OR THE NEEDLE THRU CATHETER. CATHETER/ADAPTER PULL TEST PERFORMED ON THE UNUSED UNIT: THE SPECIFICATION IS ¿ LSL 2.0LB. THE UNIT WAS ACCEPTABLE PER SPECIFICATION. CONCLUSION: INDETERMINATE: ALTHOUGH THE DEFECT CATHETER BROKE/SEPARATED AFTER PLACEMENT WAS CONFIRMED, THE ACTUAL CAUSE OF DEFECT WHETHER MANUFACTURING OR CUSTOMER, COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED 2 DAYS AFTER PLACEMENT OF A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER, WHILE FLUSHING THE DEVICE THE CATHETER MATERIAL SEPARATED FROM THE HUB AND ENTERED THE PATENT'S VASCULATURE. X-RAYS AND ULTRASOUND TESTS HAVE BEEN DONE TO FIND THE DEVICE. THE CATHETER HAS NOT BEEN FOUND, (¿STILL SEARCHING FOR THE CATHETER IN THE PATIENT¿S VASCULATURE SO THE EXTENT OF THE INJURY IS UNKNOWN¿). IT WAS ALSO REPORTED THAT SINCE THE EVENT, ¿THE PATIENT HAS SHOWN STROKE SIGNS AND SYMPTOMS¿.

    Description of Event or Problem · 0

    IT WAS REPORTED 2 DAYS AFTER PLACEMENT OF A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER, WHILE FLUSHING THE DEVICE THE CATHETER MATERIAL SEPARATED FROM THE HUB AND ENTERED THE PATENT'S VASCULATURE. X-RAYS AND ULTRASOUND TESTS HAVE BEEN DONE TO FIND THE DEVICE. THE CATHETER HAS NOT BEEN FOUND, (¿STILL SEARCHING FOR THE CATHETER IN THE PATIENT¿S VASCULATURE SO THE EXTENT OF THE INJURY IS UNKNOWN¿). IT WAS ALSO REPORTED THAT SINCE THE EVENT, ¿THE PATIENT HAS SHOWN STROKE SIGNS AND SYMPTOMS.¿

    Additional Manufacturer Narrative · 1

    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 2 DAYS AFTER PLACEMENT OF A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER, WHILE FLUSHING THE DEVICE THE CATHETER MATERIAL SEPARATED FROM THE HUB AND ENTERED THE PATENT'S VASCULATURE. X-RAYS AND ULTRASOUND TESTS HAVE BEEN DONE TO FIND THE DEVICE. THE CATHETER HAS NOT BEEN FOUND, (¿STILL SEARCHING FOR THE CATHETER IN THE PATIENT¿S VASCULATURE SO THE EXTENT OF THE INJURY IS UNKNOWN¿). IT WAS ALSO REPORTED THAT SINCE THE EVENT, ¿THE PATIENT HAS SHOWN STROKE SIGNS AND SYMPTOMS¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846349 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 30382903814337

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention