BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DILATOR

    MDR report key: 12319059 · Received August 13, 2021

    Report

    Report Number
    1820334-2021-01983
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    June 15, 2021
    Report Date
    July 20, 2022
    Manufacturer
    COOK INC
    Product Code
    DRE
    UDI-DI
    00827002013285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G4--PMA/510(K): K183036. INVESTIGATION ¿ EVALUATION. (B)(6) HOSP & CLINIC (UNITED STATES) CONTACTED COOK 03AUG2021 STATING THAT THEY FOUND A HAIR LIKE FIBER IN A JCD18.0-38-20 PACKAGE FROM LOT# 13944724. THE PACKAGE WAS NOT OPENED AND SET ASIDE TO BE RETURNED TO COOK. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, AND QUALITY CONTROL, AS WELL AS A VISUAL INSPECTION OF THE RETURNED PRODUCT, WERE CONDUCTED DURING THE INVESTIGATION. ONE PRIOR TO USE DEVICE WAS RETURNED TO COOK FOR EVALUATION. THERE WAS A HAIR LIKE FIBER THAT CAN BE SEEN NEXT TO THE DISTAL TIP OF THE DILATOR IN THE SEALED PACKAGE. 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 DEVICE HISTORY RECORD (DHR) FOR LOT# 13944724 FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THERE ARE NO ADDITIONAL COMPLAINTS FOR THIS LOT. COOK ALSO REVIEWED PRODUCT LABELING. THIS PRODUCT IS NOT SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) PAMPHLET. BASED ON THE DEVICE FAILURE ANALYSIS, DEVICE HISTORY RECORD, AND DEVICE MASTER RECORD, THERE IS EVIDENCE FOUND THAT THE PRODUCT WAS PROCESSED THROUGH QUALITY CONTROL AND MANUFACTURING OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING MATERIAL IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THE CAUSE OF THIS EVENT IS RELATED TO MANUFACTURING AND QUALITY CONTROL 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: B3. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: PREAMENDMENT. 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 A HAIR WAS NOTED WITHIN THE STERILE PACKAGING OF A DILATOR. AS THE DEVICE WAS LEFT UNOPENED, NO PATIENT CONTACT WAS MADE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216642 DILATOR DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK INC G01328 13944724 00827002013285

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown