BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DILATOR

    MDR report key: 15114266 · Received July 27, 2022

    Report

    Report Number
    1820334-2022-01286
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Date of Event
    July 19, 2022
    Report Date
    February 21, 2023
    Manufacturer
    COOK INC
    Product Code
    DRE
    UDI-DI
    00827002009967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL COMMON NAME: FGE CATHETER, BILIARY, DIAGNOSTIC. (B)(4). CUSTOMER (PERSON): POSTAL CODE: (B)(6). PMA/510(K) #: K183036. 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

    INVESTIGATION ¿ EVALUATION: (B)(6) HOSPITAL (JAPAN) CONTACTED COOK ON 19JUL2022 CONCERNING A DILATOR (RPN: JCD14.0-38-20; LOT#: 14623631). WHEN THE CUSTOMER WAS ABOUT TO OPEN THE DEVICE PACKAGING, A HAIR-LIKE FOREIGN MATTER WAS FOUND NEAR THE HANGING HOLE END OF THE PACKAGING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THIS WAS NOTED PRIOR TO USE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. 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 DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE PRODUCT WAS RETURNED TO COOK FOR EVALUATION. ONE SEALED AND UNUSED DEVICE WAS RECEIVED. A HAIR-LIKE FIBER WAS NOTED INSIDE THE SEALED POUCH ABOVE THE LABEL. THE FAILURE WAS CONFIRMED FOR THIS COMPLAINT. COOK FOUND THE PRODUCT OUT OF SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT THERE ARE PROCEDURES IN PLACE TO CHECK FOR THIS NON-CONFORMANCE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED THE DEVICE HISTORY RECORD (DHR). THE DHR FOR LOT 14623631 RECORDED NO NON-CONFORMANCES NOR ADDITIONAL COMPLAINTS. THERE IS NO EVIDENCE OF NON-CONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THIS PRODUCT IS SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) PAMPHLET, T_JCD_REV0. IN THE HOW SUPPLIED SECTION IT STATES: "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." 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 A QUALITY CONTROL DEFICIENCY. 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

    IT WAS REPORTED, THAT PRIOR TO OPENING THE SEALED PACKAGE ON A DILATOR, THE USER NOTICED A HAIR LIKE SUBSTANCE IN THE PACKAGE. THE DEVICE WAS NOT USED AND NO PATIENT CONTACT WAS MADE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    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
    1704024 DILATOR DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK INC N/A 14623631 00827002009967

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown