BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRV MINI KAMVAC SUCTION TUBE

    MDR report key: 11574770 · Received March 26, 2021

    Report

    Report Number
    1818910-2021-06224
    Event Type
    Malfunction
    Date Received
    March 26, 2021
    Date of Event
    March 19, 2021
    Report Date
    March 19, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JOL
    UDI-DI
    10603295171515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION, WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED, THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATED THE FOLLOWING: WHAT TYPE OF PROCEDURE WAS BEING PERFORMED? A HIP ARTHROPLASTY. WERE THERE ANY FRAGMENTS THAT WERE BROKEN OFF INSIDE THE PATIENT? SURGEON NOTICED, KAM VAC SUCTION TIP HAD BROKEN WHILE IN USE. IF YES, WERE THE FRAGMENTS RETRIEVED? BROKEN SUCTION TIP AND PACKAGING RETRIEVED. AND GIVEN TO PATIENT CARE COORDINATOR.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE COMPLETING A HIP ARTHROPLASTY, SURGEON NOTICED KAM VAC SUCTION TIP HAD BROKEN WHILE IN USE. SUCTION TIP REMOVED FROM STERILE SET-UP AND REPLACED BY NEW SUCTION. SURGEON SEARCHED THE FIELD FOR BROKEN PIECES AND IRRIGATED THE WOUND WITH NORMAL SALINE. SINCE XRAY WAS IN USE FOR PROCEDURE, XRAYS TAKEN OF FIELD. SURGEON STATED HE COULD NOT FIND ANY PIECES OF THE SUCTION TIP WHILE IN THE FIELD. BROKEN SUCTION TIP AND PACKAGING RETRIEVED AND GIVEN TO PATIENT CARE COORDINATOR. INCIDENT REPORT COMPLETED DURING TIME OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472662 CRV MINI KAMVAC SUCTION TUBE SURGICAL ACCESSORIES : ENVIRONMENTAL PROTECTION JOL DEPUY ORTHOPAEDICS INC US 5300-20-500 69981205 10603295171515

    Patients

    Seq Age Sex Outcome Treatment
    1