BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRV MINI KAMVAC SUCTION TUBE

    MDR report key: 11783465 · Received May 6, 2021

    Report

    Report Number
    1818910-2021-09683
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 23, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JOL
    UDI-DI
    10603295171515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE DEVICE TO EXAMINE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). WHERE THE PRODUCT AND LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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 A KAM VAC SUCTION TUBE TIP (APPROX 1CM) BROKE INTRAOPERATIVELY - XRAYS TAKEN TO RETRIEVE WERE UNSUCCESSFUL. SURGICAL DELAY REPORTED BUT LENGTH OF TIME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680368 CRV MINI KAMVAC SUCTION TUBE SURGICAL ACCESSORIES : ENVIRONMENTAL PROTECTION JOL DEPUY ORTHOPAEDICS INC US 5300-20-500 10603295171515

    Patients

    Seq Age Sex Outcome Treatment
    1