BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    MDR report key: 15257530 · Received August 19, 2022

    Report

    Report Number
    1820334-2022-01360
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Date of Event
    August 8, 2022
    Report Date
    December 16, 2022
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002064171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PMA/510K # = K182071 THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION : AS REPORTED, PRIOR TO OPENING THE PACKAGE OF A MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET, PARTICLES AND A HAIR LIKE FIBER WERE DISCOVERED INSIDE THE PACKAGE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT RETURNED ONE UNUSED MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE SHOWED AN UNKNOWN PARTICLE WAS NOTED NEAR THE BOTTOM OF THE SEALED POUCH, AS WELL AS A HAIR LIKE FIBER. ADDITIONALLY, 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. A REVIEW OF THE DHR FOR LOT NS14054092 RECORDS ONE RELEVANT NON-CONFORMANCE FOR ¿FOREIGN MATTER¿ INVOLVING ONE DEVICE. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND NO ADDITIONAL LOT RELATED COMPLAINTS FROM THE FIELD. ALTHOUGH THE LONE NON-CONFORMANCE WAS RELEVANT TO THE REPORTED FAILURE MODE, ALL NON-CONFORMING PRODUCT WAS REWORKED, THERE ARE 100% INSPECTIONS TO CAPTURE THIS NON-CONFORMANCE, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, AND THERE ARE NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, ¿MULTI-SIDEPORT CATHETER INFUSION SET WITH DUAL CHECK VALVE,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ THE INFORMATION PROVIDED UPON REVIEW OF PRODUCT LABELING REVIEW, DEVICE MASTER RECORD AND DEVICE HISTORY RECORD, THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. COOK HAS CONCLUDED THAT THIS WAS AN ISOLATED INCIDENT, AND THAT NO ADDITIONAL NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. COOK HAS CONCLUDED THAT CAUSE OF THIS FAILURE IS A MANUFACTURING AND QUALITY CONTROL DEFICIENCY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE 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

    AS REPORTED, PRIOR TO OPENING THE PACKAGE OF AN MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET, PARTICLES AND A HAIR LIKE FIBER WERE DISCOVERED INSIDE THE PACKAGE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847813 MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC G06417 NS14054092 00827002064171

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown