BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    DISP. 34X4, 1BLA, 1PRT, QUICK CONNECT

    MDR report key: 16261798 · Received January 29, 2023

    Report

    Report Number
    3015967359-2023-00141
    Event Type
    Malfunction
    Date Received
    January 29, 2023
    Date of Event
    December 31, 2022
    Report Date
    July 27, 2023
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    KCY
    UDI-DI
    37613154599456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE CORRECTED DATA: B5, H6, H10 2 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, - 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 3015967359-2023-00145. - 1 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 1 DEVICE WAS NOT AVAILABLE FOR EVALUATION. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 2 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 2 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 2 DEVICES WERE LABELED FOR SINGLE-USE. 2 DEVICES WERE NOT REPROCESSED OR REUSED.

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE CORRECTED DATA: B5, H10 2 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 2 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16011 DISP. 34X4, 1BLA, 1PRT, QUICK CONNECT TOURNIQUET, PNEUMATIC KCY STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP VMSR 37613154599456

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown