BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ANGIOCATH-N¿, BD AUTOGUARD¿

    MDR report key: 5148453 · Received October 14, 2015

    Report

    Report Number
    1710034-2015-00012
    Event Type
    Injury
    Date Received
    October 14, 2015
    Date of Event
    September 21, 2015
    Report Date
    March 30, 2016
    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
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: LOT NUMBER 5063227 IS NOT A VALID LOT NUMBER. ONE USED PIECE OF CATHETER TUBING FROM A 24G BD ANGIOCATH-N AUTOGUARD FROM AN UNKNOWN LOT NUMBER WAS RECEIVED. IN ADDITION, A TOTAL OF 39 UNUSED UNITS WITHIN SEALED PACKAGES WERE RECEIVED AS FOLLOWS: 6 UNITS FROM LOT NUMBER 4059581, 6 UNITS FROM LOT NUMBER 5002915, 7 UNITS FROM LOT NUMBER 4203557, AND 20 UNITS FROM LOT NUMBER 5063827. NO UNITS WERE RECEIVED FOR LOTS 3289840 OR 3106688. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO ABNORMALITIES DURING THE MANUFACTURE FOR THE REPORTED LOT NUMBERS ASSOCIATED WITH THIS INCIDENT OTHER THAN ONE QUALITY NOTIFICATION FOR LOT 5063827, "SUSPECT BASE SPEAR", WHICH COULD BE POTENTIALLY RELATED TO THIS INCIDENT. VISUAL/MICROSCOPIC EXAMINATION: THE RETURNED PIECE OF CATHETER TUBING WAS 18MM LONG. THE END EDGE OF THE CATHETER TUBING HAD REVEALED STRETCH AND STRESS SIGNS WITH A POSSIBLE "V" SHAPED CUT ON ONE OF ITS SIDES. LOTS 4059581, 5002915 AND 4203557: NO PHYSICAL-MECHANICAL DAMAGE WAS OBSERVED ON ANY OF THE AREAS OF THE UNITS. A WATER/AIR LEAK TEST WAS PERFORMED AND NO LEAKAGE WAS OBSERVED. LOT 5063827: ONE OF THE 20 UNITS RECEIVED FROM THIS LOT REVEALED A DARK PIECE OF FOREIGN MATTER (FM) EMBEDDED AT ABOUT 5MM FROM THE NOSE OF THE ADAPTER. THE UNIT REVEALED A SMALL HOLE RIGHT ABOVE THE PARTICLE OF FM. THE TUBING WAS CUT OPEN TO EVALUATE THE INSIDE OF THE TUBING. THE FM WAS EMBEDDED INTO THE TUBING BUT IT DID NOT GO THROUGH IT. THE REMAINING 19 UNITS DID NOT REVEAL ANY PHYSICAL-MECHANICAL DAMAGE. A WATER/AIR LEAK TEST WAS PERFORMED. WATER LEAKAGE AND AIR BUBBLES WERE OBSERVED COMING FROM THE HOLE ON THE TUBING. THE REMAINDER OF THE 19 UNITS DID NOT LEAK. CONCLUSIONS: THE REPORTED DEFECT WAS CONFIRMED. A PARTIAL PIECE OF TUBING WHICH REVEALED SIGNS OF STRETCHING WAS RECEIVED. ONE OF THE 20 UNITS RECEIVED FOR LOT NUMBER 5063827 REVEALED A HOLE WHICH COULD BE A CONTRIBUTIVE FACTOR FOR THE SEPARATION EXPERIENCED BY THE CUSTOMER. THE ROOT CAUSE FOR THE REPORTED INCIDENT IS MANUFACTURING. A MISS-ALIGNED SET TOGETHER STATION COULD CAUSE THE TIP OF THE CANNULA TO SPEAR THRU THE CATHETER TUBING. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING REPORTED POTENTIAL LOT NUMBERS FOR THIS INCIDENT WERE INCLUDED IN FIELD ACTION REFERENCE MSS-16-759-FA: 3106688, 3289840, 4059581, 4203557, 5002915, 5063827. ADDITIONAL POTENTIAL LOT NUMBERS WERE PROVIDED WITH THIS COMPLAINT AND ARE ALSO ASSOCIATED WITH THE ABOVE FIELD ACTION FOR CATALOG 381700. HOWEVER, THESE ARE NOT ASSOCIATED WITH THE CATALOG NUMBER IDENTIFIED IN THE CUSTOMER COMPLAINT (CATALOG 381720) AND WERE THEREFORE NOT INCLUDED ON THE INITIAL MDR: 3143801, 4051735, 4219570, 4317642, 5063833. THE CUSTOMER ALSO PROVIDED LOT NUMBER 5063227. THIS IS NOT A VALID BD LOT NUMBER, WHICH WAS NOTED IN SUPPLEMENTAL (B)(4).

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE UNKNOWN AS LOT NUMBER IS UNKNOWN. POSSIBLE LOT NUMBERS PROVIDED FOR THE GIVEN MEDICAL DEVICE CATALOG NUMBER - 4203557, 5002915, 3289840, 3106688, 5063827, 4059581, 5063227. DEVICE MANUFACTURE DATE UNKNOWN AS LOT NUMBER IS UNKNOWN. EVALUATION: A QUALITY NOTIFICATION REVIEW INDICATES NO QUALITY NOTIFICATIONS GENERATED FOR POTENTIAL LOTS 3289840, 4203557, 3106688, 4059581, 5002915 OR 5063227. ONE QUALITY NOTIFICATION, "SUSPECT BASE SPEAR", WAS RAISED POTENTIALLY RELATED TO THE REPORTED CONDITION DURING THE PRODUCTION OF POTENTIAL LOT 5063827. A SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. A SAMPLE IS AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN CHECKING THE PATIENT'S IV AT 0300 ON (B)(6), THE NURSE NOTED FLUID LEAKING FROM UNDER THE TAGEDERM. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. THE NURSE HELD PRESSURE TO THE SITE AND THEN COVERED IT WITH GAUZE. WHEN THE GAUZE WAS REMOVED AT 0830 ON (B)(6), THE CATHETER WAS FOUND STICKING OUT OF THE SKIN. THE CATHETER WAS EASILY RETRIEVED WITH TWEEZERS AND THE PATIENT HAD AN X-RAY AND ULTRASOUND TO THE ARM. THERE WERE NO ADDITIONAL CLINICAL CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680111 BD ANGIOCATH-N¿, BD AUTOGUARD¿ SHIELDED IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention