BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 12572534 · Received October 4, 2021

    Report

    Report Number
    1820334-2021-02282
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Report Date
    August 22, 2022
    Manufacturer
    COOK INC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H6- ANNEX A. INVESTIGATION ¿ EVALUATION. (B)(6) CENTER (UNITED STATES) CONTACTED COOK STATING THAT THEY HAD A BROKEN ART LINE. THE CUSTOMER DID NOT PROVIDE ANY PATIENT OUTCOME OR PROCEDURE DETAILS TO AID IN THE INVESTIGATION. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING THE RPN OR COMPONENT OF THE COMPLAINT DEVICE. COOK BECAME AWARE OF THIS EVENT ON 21SEP2021. THIS INVESTIGATION WILL PROCEED BASED ON THE ASSUMPTION THAT "BROKEN ART LINE" MEANS THAT THE CATHETER COMPONENT OF THE PRESSURE MONITORING SET FRACTURED. REVIEWS OF DOCUMENTATION INCLUDING THE QUALITY CONTROL AND INSTRUCTIONS FOR USE (IFU), WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED, AND NO PHOTOGRAPHS WERE PROVIDED TO AID IN THE INVESTIGATION; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER TO AID IN THE INVESTIGATION. A SALES REPORT WAS PERFORMED HOWEVER COOK WAS NOT ABLE TO ASCERTAIN A LOT NUMBER TO REVIEW THE DEVICE HISTORY RECORD. COOK WAS NOT ABLE TO DETERMINE NON-CONFORMING MATERIAL IN HOUSE OR IN THE FIELD. A REVIEW OF CAPAS, FARS, PENS, AND SCARS WAS PERFORMED. FAR-2021-017 WAS SUBMITTED FOR VARIOUS PMS CATHETERS FOR FAILURE OF TENSILE STRENGTH TESTING. IT IS POSSIBLE THAT THIS FAR IS RELATED TO THIS FAILURE. THERE ARE NO CAPAS, OR PENS OPENED OR CLOSED RELATED TO THIS FAILURE. COOK WAS NOT ABLE TO PROPERLY REVIEW SCARS DUE TO THE LACK OF A LOT NUMBER TO GET A WORK ORDER. BASED ON THE AVAILABLE INFORMATION, COOK WAS NOT ABLE TO FIND EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION AND COOK WAS NOT ABLE TO FIND EVIDENCE OF NON-CONFORMING MATERIAL IN HOUSE OR IN FIELD. THE CUSTOMER DID NOT PROVIDE A SPECIFIC RPN FOR THIS COMPLAINT. A LOOK AT THE POSSIBLE RPN¿S FOR THIS CUSTOMER, THERE ARE TWO THAT HAVE AND INSTRUCTIONS FOR USE (IFU) PAMPHLET AND THE REST DO NOT HAVE AN IFU. IFU C_T_ULMBH_REV7 FOR PMSY KITS STATES IN THE HOW SUPPLIED SECTION: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. IFU C_T_ULMBHCE_REV8 FOR PMS 250 SERIES KITS IN THE HOW SUPPLIED SECTION: UPON REMOVAL FROM PACKAGE, INSPECT PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE AVAILABLE INFORMATION, NO DEVICE RETURN, AND THE RESULTS OF THE INVESTIGATION, COOK WAS NOT ABLE TO DETERMINE A CAUSE FOR THIS FAILURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    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 THAT AN UNKNOWN COOK DEVICE "BROKE". THE DEVICE WAS DESCRIBED TO BE AN "ART LINE", AND IS CURRENTLY PRESUMED TO BE AN ARTERIAL PRESSURE MONITORING SET. ADDITIONAL INFORMATION REGARDING CLARIFICATION OF THE FAILURE MODE, AS WELL AS PATIENT, DEVICE, AND EVENT DETAILS, HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471214 UNKNOWN Catheter, percutaneous DQY COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown