BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATLOCK PICC PLUS STABILIZATION DEVICE

    MDR report key: 7038844 · Received November 16, 2017

    Report

    Report Number
    3006260740-2017-02043
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Report Date
    May 8, 2018
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, FREQUENCY ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF THE INABILITY TO CLOSE A STATLOCK DEVICE IS CONFIRMED AND WAS DETERMINED TO BE USE RELATED. THREE PICC PLUS STATLOCK DEVICES WITH FOAM PADS AND FIXED POSTS WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED THE UPPER RIGHT LOCKING BARBS OF ALL THREE SAMPLES WERE BENT. THE UPPER LEFT LOCKING BARB OF SAMPLE 3 WAS OBSERVED TO BE SLIGHTLY BENT AND THE UPPER LEFT LOCKING BARB OF SAMPLE 2 WAS OBSERVED TO BE MISSING. THE LEFT DOOR OF SAMPLE 1 WAS ABLE TO BE CLOSED AND LOCKED, BUT THE RIGHT DOOR WAS UNABLE TO BE LOCKED DUE TO THE BENT LOCKING BARB AND THE RIGHT DOOR WAS OBSERVED TO BE MISALIGNED. NEITHER OF THE DOORS OF SAMPLE 2 WERE ABLE TO LOCK DUE TO THE BENT LOCKING BARB ON THE RIGHT DOOR AND THE MISSING LOCKING BARB ON THE LEFT DOOR. NEITHER OF THE DOORS OF SAMPLE 3 WERE ABLE TO LOCK DUE TO THE BENT UPPER RIGHT AND UPPER LEFT LOCKING BARBS. A MICROSCOPIC OBSERVATION REVEALED THE CREASE IN THE HINGE OF THE RIGHT DOOR OF SAMPLE 1 WAS DIAGONAL AND DAMAGE WAS OBSERVED ON THE POINT OF CONTACT OF THE BENT UPPER LOCKING BARB ON THE RETAINER. THE CREASES IN THE HINGE OF BOTH DOORS OF SAMPLE 2 WERE OBSERVED TO BE SLIGHTLY DIAGONAL. DAMAGE WAS OBSERVED ON THE BENT UPPER RIGHT LOCKING BARB OF SAMPLE 2 AS WELL AS AT ITS POINT OF CONTACT ON THE RETAINER, AND THE MISSING UPPER LEFT LOCKING BARB APPEARED TO BE HAVE BEEN BROKEN OFF. THE CREASES IN THE HINGE OF BOTH DOORS OF SAMPLE 3 WERE OBSERVED TO BE SLIGHTLY DIAGONAL AND DAMAGE WAS OBSERVED ON THE UPPER RIGHT AND UPPER LEFT LOCKING BARBS AS WELL AS ON THEIR POINTS OF CONTACT ON THE RETAINER. THE NATURE OF THE DAMAGE OBSERVED ON THE LOCKING BARBS OF THE RETURNED SAMPLES AND THEIR POINTS OF CONTACT ON THE RETAINERS AS WELL AS THE CHARACTERISTICS OF THE HINGE DAMAGE ARE EVIDENCE THAT THE LOCKING BARBS WERE BENT AND DAMAGED DUE TO MISALIGNMENT OF THE DOOR WHEN CLOSING THE DEVICE. PUSHING THE DOOR AT AN ANGLE CAN CAUSE THE LOCKING BARB TO MISS THE CATCH ON THE RETAINER AND CAN PERMANENTLY BEND THE BARB. THIS ISSUE CAN BE AVOIDED BY CENTERING THE THUMB ABOUT THE MIDDLE OF THE DOOR AND PRESSING DIRECTLY DOWNWARDS. AN EXAMINATION OF THE SAMPLE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT APPEARED TO BE A REPORTABLE OCCURRENCE. ONCE THE SAMPLE WAS RETURNED AND EVALUATED IT WAS FOUND THE CLINICIAN WOULD HAVE BEEN UNABLE TO CLOSE THE DEVICE DURING INITIAL APPLICATION; THEREFORE, THERE IS NO RISK OF INADVERTENT CATHETER MALPOSITION. THE INFORMATION PROVIDED DOES NOT REASONABLY SUGGEST THE EVENT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OF A PATIENT, USER OR OTHER PERSON. THEREFORE THIS EVENT IS DEEMED NOT REPORTABLE PER 21 CFR PART 803.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT. DEVICE NOT RETURNED YET.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT A BAG OF FAULTY STATLOCKS WERE RECEIVED AS PART OF S/L PICC LINE KIT . THE STATLOCK CATCH/DOORS KEEP OPENING. THIS FILE REFERENCES DEVICE THREE OF THREE.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT A BAG OF FAULTY STATLOCKS WERE RECEIVED AS PART OF S/L PICC LINE KIT . THE STATLOCK CATCH/DOORS KEEP OPENING. THIS FILE REFERENCES DEVICE THREE OF THREE.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT A BAG OF FAULTY STATLOCKS WERE RECEIVED AS PART OF S/L PICC LINE KIT . THE STATLOCK CATCH/DOORS KEEP OPENING. THIS FILE REFERENCES DEVICE THREE OF THREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815812 STATLOCK PICC PLUS STABILIZATION DEVICE STATLOCK PICC PLUS STABILIZATION DEVICE KMK BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1