BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL ARTERY PRESSURE MONITORING SET

    MDR report key: 8768422 · Received July 8, 2019

    Report

    Report Number
    1820334-2019-01631
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 24, 2019
    Report Date
    August 26, 2019
    Manufacturer
    COOK INC
    Product Code
    DQO
    UDI-DI
    00827002020924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL, AND PHOTOS OF THE COMPLAINT DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED, AS THE COMPLAINT DEVICE WAS NOT RETURNED; HOWEVER PHOTOS OF THE COMPLAINT DEVICE WERE RECEIVED AND USED IN THE INVESTIGATION. THE PHOTOS CONFIRMED THE PRESENCE OF A PARTICLE OF FOREIGN MATTER WITHIN THE SEALED PACKAGING OF THE DEVICE. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 9211173 SHOWED NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER. THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE CAN BE TRACED TO MANUFACTURING AND A QUALITY CONTROL DEFICIENCY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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 OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    OCCUPATION: UNKNOWN. PMA/510(K) #: PRE-AMENDMENT. 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

    IT WAS REPORTED AN UNIDENTIFIABLE PARTICLE WAS FOUND IN THE PRIMARY PACKAGING OF A RADIAL ARTERY PRESSURE MONITORING SET. THE PARTICLE WAS FOUND BY A THIRD PARTY DISTRIBUTOR. THE DEVICE DID NOT MAKE PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563584 RADIAL ARTERY PRESSURE MONITORING SET DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK INC N/A 9211173 00827002020924

    Patients

    Seq Age Sex Outcome Treatment
    1