BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCK PERICARDIOCENTESIS CATHETER SET

    MDR report key: 11357575 · Received February 22, 2021

    Report

    Report Number
    1820334-2021-00363
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    February 15, 2021
    Report Date
    May 18, 2021
    Manufacturer
    COOK INC
    Product Code
    GBX
    UDI-DI
    10827002024332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE PACKAGING OF TWO LOCK PERICARDIOCENTESIS CATHETER SETS FROM LOT 13651359. COOK BECAME AWARE OF THIS EVENT UPON BEING NOTIFIED BY MEDIK INC. THIS WAS NOTED BY A DISTRIBUTOR SO THE DEVICES DID NOT MAKE PATIENT CONTACT. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION OF THE RETURNED PRODUCTS, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICES WERE RETURNED SEALED IN THEIR ORIGINAL PACKAGING. DARK FIBERS AND/OR SPECKS ARE VISIBLE WITHIN THE PACKAGING. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. REVIEW OF THE DEVICE MASTER RECORD HAS SHOWN THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. THE PRODUCT¿S DESIGN HISTORY FILE (DHF) WAS REVIEWED AND THE RISKS ASSOCIATED WITH THIS DEVICE WERE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. UPON REMOVAL FROM PACKAGE INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS ALSO CONDUCTED AS A PART OF THE INVESTIGATION TO CHECK FOR FAILURE RELATED NONCONFORMANCES AND ADDITIONAL COMPLAINTS. THE DHR FOR THE COMPLAINT LOT SHOWED NO NONCONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS UNDER THIS LOT NUMBER AT THE TIME OF THIS INVESTIGATION. ALL DEVICES FROM THIS LOT WERE SENT TO THE SAME DISTRIBUTOR AND NO OTHER DEVICES WERE REPORTED WITH THIS FAILURE. SINCE NO OTHER PRODUCTS FROM THIS LOT WERE REPORTED BY THE DISTRIBUTOR TO EXPERIENCE THIS FAILURE, THERE IS NO EVIDENCE THAT ADDITIONAL NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, CONFIRMATION OF FIBERS WITHIN THE SEALED PACKAGING, AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT A MANUFACTURING DEFICIENCY CONTRIBUTED TO THE FAILURE MODE. 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

    THIS OCCURRED WITH TWO DEVICES OF THE SAME LOT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER NAME AND ADDRESS: (B)(6). INITIAL REPORTER OCCUPATION: DISTRIBUTOR. PMA/510(K) #: EXEMPT. 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 TO COOK BY A DISTRIBUTOR THAT UNKNOWN FOREIGN MATTER WAS FOUND WITHIN THE UNOPENED PACKAGING OF A LOCK PERICARDIOCENTESIS CATHETER SET. NO PATIENT CONTACT WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256459 LOCK PERICARDIOCENTESIS CATHETER SET GBX CATHETER, IRRIGATION GBX COOK INC 13651359 10827002024332

    Patients

    Seq Age Sex Outcome Treatment
    1