BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1IN.BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 6880100 · Received September 20, 2017

    Report

    Report Number
    1710034-2017-00211
    Event Type
    Malfunction
    Date Received
    September 20, 2017
    Date of Event
    July 20, 2017
    Report Date
    October 6, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: RECEIVED ONE 20GA USED UNIT CONSISTING ON A CATHETER-ADAPTER EXTENSION SET WITH A Q-SYTE UNIT CONNECTED TO ONE OF ITS PORTS AND A VENT PLUG TO ANOTHER, ALONG WITH A NEEDLE COVER AND AN ADDITIONAL Q-SYTE UNIT. THE UNIT WAS WITHIN AN OPEN PACKAGE FROM LOT NUMBER 7040645. THE UNIT HAD TRACES OF PATIENT RESIDUE (BLOOD) ON THE EXTENSION SET, THE CATHETER TUBING AND WITHIN THE UNIT, TRACES OF LEAKAGE WAS OBSERVED AROUND THE CANISTER AND THE SEPTUM. WATER/AIR LEAK TEST WAS PERFORMED BY CONNECTING THE END OF THE LAB SUPPLIED MALE SLIP LUER TEST FITTING TO THE ADAPTER. ALTHOUGH NO LEAKAGE WAS OBSERVED THE UNIT WAS SEVERELY OCCLUDED NOT ALLOWING THE AIR TO PASS THROUGH THE UNIT. THE UNIT WAS DISSECTED AND THE SEPTUM WAS MICROSCOPICALLY OBSERVED, THE UNIT REVEALED THE TOP OF THE SEPTUM HAD BEEN PIERCED (CORING OF THE PRIMARY SEPTUM) BY THE CANNULA. THE SLIT WAS PRESENT PER SPECIFICATION. ALTHOUGH THE UNIT DID NOT LEAK DURING THE PERFORMANCE OF THE WATER LEAK TEST THE CONDITION OF THE SEPTUM TOP (CORED) CONFIRMED THE CUSTOMER¿S EXPERIENCE OF LEAKING AT SEPTUM WITH THE BD PRODUCT. THE DAMAGE CAN OCCUR DURING ASSEMBLY WHEN THE CANNULA BACKEND IS INSERTED THROUGH A SLIT IN THE SEPTUM. HOWEVER, DURING THE INVESTIGATION, NOTHING ABOUT THE PROCESS WAS IDENTIFIED AS A ROOT CAUSE. PROJECT ACR (B)(4) REDESIGNED THE CANNULA AND SEPTUM WHICH CHANGED THE INSERTION PROCESS. THE CHANGE IN THE PROCESS IS EXPECTED TO REDUCE THE OCCURRENCE OF THIS DEFECT. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THE CUSTOMER REPORTED CAT # 382523 AND LOT # 7040645 FOR THIS INCIDENT. HOWEVER, ACCORDING TO MANUFACTURING RECORDS, LOT # 7040645 DOES NOT EXIST FOR CAT # 382523. THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE 22 G X 1IN. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL WAS INSERTED, BLOOD STARTED LEAKING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658856 22 G X 1IN.BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7040645

    Patients

    Seq Age Sex Outcome Treatment
    1 Other