BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD TRAY BONANNO CATHETER S/SU

    MDR report key: 9666330 · Received February 4, 2020

    Report

    Report Number
    2618282-2020-00003
    Event Type
    Injury
    Date Received
    February 4, 2020
    Date of Event
    January 8, 2020
    Report Date
    March 12, 2020
    Manufacturer
    BD CARIBE LTD.
    Product Code
    FEZ
    UDI-DI
    00382904082895
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 408289 LOTS 7201648 AND 5280953 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE DEVICE HISTORY REVIEW SHOWS NO INDICATION OF THE REPORTED DEFECT OR NONCONFORMANCES AS IT RELATED TO THE MANUFACTURING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER REMOVAL OF DRAIN PART OF IT REMAINED INSIDE PATIENT WITH A BD TRAY BONANNO CATHETER S/SU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PATIENT WAS ADMITTED WITH CIRRHOSIS AND ASCITES. (B)(6) 2020 TRIAL FOR ASCETIC DRAIN INSERTION ATTEMPTED WITH NO SUCCESS. NEXT MONDAY (B)(6) 2020 DRAIN INSERTED AFTER US MARKING OF THE LOCATION. DRAIN INSERTED AT 1730, BY ME WITH SPR PRESENCE, WITH SOME DIFFICULTY DUE TO PATIENT BODY HABITUS, BUT NO OBVIOUS CONCERNS. NIGHT STAFF DID NOT REMOVE DRAIN UNTIL THE NEXT DAY, HOWEVER, IT WAS CLAMPED. THE DRAIN WAS REMOVED BY ME THE NEXT DAY. HOWEVER, PART OF IT WAS MISSING (NEARLY 10 CM). I AM UNSURE WHAT MIGHT HAVE CAUSED THIS. QGM (RP): ALERTED TO THE INCIDENT BY WARD MANAGER, FOR WHICH TWO ISSUES CAME TO MIND IMMEDIATELY; I) POTENTIAL NEVER EVENT AS IS A RETAINED FOREIGN BODY, AND II) AN MHRA NOTIFIABLE INCIDENT, DUE TO THE DRAIN POTENTIALLY BEING PART OF A FAULTY BATCH. IN RELATION TO THE TWO POINTS ABOVE: I) DISCUSSED THE INCIDENT WITH THE PATIENT SAFETY LEAD AND ASSOCIATE DIRECTOR OF QUALITY GOVERNANCE. REVIEW OF THE NEVER EVENTS LIST CONFIRMED THIS IS NOT A NEVER EVENT, DUE TO THE SECOND BULLET POINT OF EXCEPTIONS UNDER THE FOREIGN BODY SECTION, WHICH OUTLINES AN EXCEPTION OF THE RETAINED FOREIGN BODY BEING KNOWN ABOUT, LEFT INTENTIONALLY AS NOT IMMEDIATELY RETRIEVABLE AND FOR REMOVAL AT A LATER DATE. II) LIAISED WITH THE WARD MANAGER WHO WAS FINDING THE DETAILS OF THE DRAIN AND THEN FORWARDING THEM TO THE PATIENT SAFETY MANAGER, WHO WILL NOTIFY MHRA. PATIENT SITUATION: THE PATIENT IS NOW TO BE MOVED TO WARD 14, BUT THE SURGEONS WILL NOT REMOVE THE RETAINED PART OF THE DRAIN AT THE MOMENT DUE TO THE PATIENT'S PRE-EXISTING OEDEMA. THE PATIENT WAS INFORMED ABOUT WHAT HAPPENED. I SPOKE WITH RADIOLOGIST AND ARRANGED AN AXR, THEN CTAP TO LOCATE THE MISSING PART OF THE DRAIN AND INFORMED THE SURGICAL TEAM.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE "POSSIBLE" LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5280953, MEDICAL DEVICE EXPIRATION DATE: 2020-10-31, DEVICE MANUFACTURE DATE: 2015-11-10. MEDICAL DEVICE LOT #: 7201648, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2017-08-25. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER REMOVAL OF DRAIN PART OF IT REMAINED INSIDE PATIENT WITH A BD TRAY BONANNO CATHETER S/SU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PATIENT WAS ADMITTED WITH CIRRHOSIS AND ASCITES. (B)(6) 2020 TRIAL FOR ASCETIC DRAIN INSERTION ATTEMPTED WITH NO SUCCESS. NEXT MONDAY (B)(6) 2020 DRAIN INSERTED AFTER US MARKING OF THE LOCATION. DRAIN INSERTED AT 1730, BY ME WITH SPR PRESENCE, WITH SOME DIFFICULTY DUE TO PATIENT BODY HABITUS, BUT NO OBVIOUS CONCERNS. NIGHT STAFF DID NOT REMOVE DRAIN UNTIL THE NEXT DAY, HOWEVER, IT WAS CLAMPED. THE DRAIN WAS REMOVED BY ME THE NEXT DAY. HOWEVER, PART OF IT WAS MISSING (NEARLY 10 CM). I AM UNSURE WHAT MIGHT HAVE CAUSED THIS. QGM (RP): ALERTED TO THE INCIDENT BY WARD MANAGER, FOR WHICH TWO ISSUES CAME TO MIND IMMEDIATELY; I) POTENTIAL NEVER EVENT AS IS A RETAINED FOREIGN BODY, AND II) AN (B)(6) NOTIFIABLE INCIDENT, DUE TO THE DRAIN POTENTIALLY BEING PART OF A FAULTY BATCH. IN RELATION TO THE TWO POINTS ABOVE: DISCUSSED THE INCIDENT WITH THE PATIENT SAFETY LEAD AND ASSOCIATE DIRECTOR OF QUALITY GOVERNANCE. REVIEW OF THE NEVER EVENTS LIST CONFIRMED THIS IS NOT A NEVER EVENT, DUE TO THE SECOND BULLET POINT OF EXCEPTIONS UNDER THE FOREIGN BODY SECTION, WHICH OUTLINES AN EXCEPTION OF THE RETAINED FOREIGN BODY BEING KNOWN ABOUT, LEFT INTENTIONALLY AS NOT IMMEDIATELY RETRIEVABLE AND FOR REMOVAL AT A LATER DATE. LIAISED WITH THE WARD MANAGER WHO WAS FINDING THE DETAILS OF THE DRAIN AND THEN FORWARDING THEM TO THE PATIENT SAFETY MANAGER, WHO WILL NOTIFY (B)(6). PATIENT SITUATION: THE PATIENT IS NOW TO BE MOVED TO WARD 14, BUT THE SURGEONS WILL NOT REMOVE THE RETAINED PART OF THE DRAIN AT THE MOMENT DUE TO THE PATIENT'S PRE-EXISTING OEDEMA. THE PATIENT WAS INFORMED ABOUT WHAT HAPPENED. I SPOKE WITH RADIOLOGIST AND ARRANGED AN AXR, THEN CTAP TO LOCATE THE MISSING PART OF THE DRAIN AND INFORMED THE SURGICAL TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129525 BD TRAY BONANNO CATHETER S/SU SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES FEZ BD CARIBE LTD. 408289 SEE H.10 00382904082895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other