BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKET KCH FETAL BLADDER DRAIN

    MDR report key: 10866562 · Received November 19, 2020

    Report

    Report Number
    3002808026-2020-12345
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 28, 2020
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    MPR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    AN ERROR HAS BEEN MADE IN WHICH MATERIAL OF AN INFERIOR QUALITY WAS USED IN THE MANUFACTURE OF THE DEVICE. IT IS UNDERSTOOD THAT THE DIFFERENCE IN THE QUALITY OF THE MATERIALS IS LIMITED TO QUALITY CONTROLS AROUND THEIR MANUFACTURE, THE MATERIAL USED IN MANUFACTURE HAVING LOWER CONTROLS. WE DO NOT KNOW THE IMPACT OF THE USE OF THE INCORRECT MATERIAL: A REVIEW IS UNDERWAY. IN THE MEANTIME, WE HAVE SUSPENDED PRODUCT SALES AND WE ARE ISSUING THIS FIELD SAFETY NOTICE TO ADDRESS PRODUCT IN THE FIELD. NO INCIDENTS HAVE BEEN REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337838 ROCKET KCH FETAL BLADDER DRAIN SUPRAPUBIC DRAINAGE CATHETER MPR ROCKET MEDICAL PLC PLEASE SEE ATTACHED FSN.

    Patients

    Seq Age Sex Outcome Treatment
    1