BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD BONNANO¿ SUPRAPUBIC CATHETER TRAY

    MDR report key: 6381873 · Received March 6, 2017

    Report

    Report Number
    2618282-2017-00002
    Event Type
    Injury
    Date Received
    March 6, 2017
    Date of Event
    January 31, 2017
    Report Date
    May 26, 2017
    Manufacturer
    BD CARIBE LTD.
    Product Code
    FEZ
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLETE MEDICAL DEVICE BRAND NAME: BD BONNANO¿ SUPRAPUBIC CATHETER TRAY: 14 G X 11 IN. FEP POLYMER CATHETER, 18 G PUNCTURE NEEDLE, ADAPTER CLAMP. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION CONFIRMED THE CUSTOMER'S REPORTED DEFECT (CATHETER BREAK/SEPARATION AFTER PLACEMENT). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6144689. CONCLUSION: ALTHOUGH THE RETURNED SAMPLE CONFIRMED THE CUSTOMER'S REPORTED DEFECT, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR TAPPING OF ASCITES. WHEN THE PIGTAIL CATHETER IN THE BD BONNANO¿ SUPRAPUBIC CATHETER TRAY WAS BEING INSERTED INTO THE PATIENT'S ABDOMEN, THE CATHETER SNAPPED OFF AND THE DISTAL PART WAS RETAINED IN THE PATIENT'S ABDOMEN. THE SURGICAL TEAM ATTEMPTED TO RETRIEVE THE MISSING PIECE THROUGH THE SKIN BUT WAS NOT SUCCESSFUL. THE PATIENT FINALLY WENT TO THE OPERATING THEATER AND HAD A LAPAROSCOPY, DRAINAGE OF ASCITES, AND RETRIEVAL OF THE RETAINED CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163240 BD BONNANO¿ SUPRAPUBIC CATHETER TRAY SUPRAPUBIC CATHETER TRAY FEZ BD CARIBE LTD. 6144689

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention