BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS PEDIATRIC ACCESS SET

    MDR report key: 8767437 · Received July 8, 2019

    Report

    Report Number
    1820334-2019-01626
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Report Date
    August 27, 2019
    Manufacturer
    COOK INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION: REVIEWS OF THE DRAWING, MANUFACTURER¿S INSTRUCTIONS, AND QUALITY CONTROL WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWINGS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT NO CAUSE COULD BE DETERMINED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    OCCUPATION: NON-HEALTHCARE PROFESSIONAL . PMA/510(K) NUMBER: K171275. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, DURING UNKNOWN PROCEDURES, THE TIP OF THE MICROPUNCTURE TRANSITIONLESS PEDIATRIC ACCESS SET WIRE SHEARED OFF "SEVERAL TIME." THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN A PATIENT'S BODY, THAT A PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT A PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENTS' ANATOMY DETAILS AND OUTCOMES HAVE BEEN REQUESTED, BUT ARE NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563751 MICROPUNCTURE TRANSITIONLESS PEDIATRIC ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1