BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-STREAM TUBING SETS

    MDR report key: 12828346 · Received November 17, 2021

    Report

    Report Number
    1213643-2021-20424
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 28, 2021
    Report Date
    November 9, 2021
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    GCJ
    UDI-DI
    00801741010095
    PMA / PMN Number
    K003790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE BARD/DAVOL X-STREAM QD ADAPTER ON THE ND TRUMPET VALVE BROKE OFF. THE X-STREAM ND TRUMPET VALVE WAS RETURNED FOR EVALUATION. VISUAL EVALUATION OF THE SAMPLE FINDS THAT THE QC ADAPTER IS BROKEN WITH A PIECE REMAINING SCREWED INTO THE ND TRUMPET VALVE BODY. THERE WERE NO MANUFACTURING ANOMALIES FOUND. OVERTIGHTENING THE ADAPTER OR APPLYING EXCESSIVE SIDE LOAD TO THE TIP DURING USE OR REMOVING THE ND TIP AT AN ANGLE COULD HAVE RESULTED IN BREAKING THE QC ADAPTER. BASED ON THE SAMPLE EVALUATION AND INVESTIGATION PERFORMED, THE MOST PROBABLE ROOT CAUSE IS LIKELY THE RESULT OF FORCES APPLIED WHILE IN USE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION, WITH NO INDICATION OF A MANUFACTURING RELATED CAUSE FOR THE EVENT REPORTED. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FROM THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN JULY, 2021. NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS (B)(6) 2021 BASED ON THE DATE OF AWARENESS.

    Description of Event or Problem · 0

    AS REPORTED, DURING A ROBOTIC HYSTERECTOMY PROCEDURE, THE QD ADAPTER OF THE BARD/DAVOL X-STREAM TUBING SET ON THE ND TRUMPET VALVE BROKE OFF DURING USE. IT WAS REPORTED THAT THE PIECE THAT BROKE OFF WAS RETRIEVED AND THE OR STAFF USED A DIFFERENT DEVICE TO FINISH THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729580 X-STREAM TUBING SETS LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA JUFT0598 00801741010095

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other