MAUDE Adverse Event Report: BECTON-DICKINSON BD BONANNO SUPRAPUBIC CATHETER

Model Number 408289

Device Problems Bent (1059); Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/20/2015

Event Type  Injury  

Event Description

Physician surgically installed (b)(4) bonnano suprapubic bladder catheter on (b)(6) 2015.Catheter bent up inside pt that date.Pt noted exterior mounting plate was at odd angle (b)(6) 2015.Physician noted suprapubic catheter was bent and at an odd angle during office visit (b)(6) 2015.Urine leaking from beneath catheter securing plate (b)(6) 2015.Physician sent pt home (b)(6) 2015.Second physician noted suprapubic catheter was bent during (b)(6) 2015 office visit.Interior suprapubic catheter snapped at one of the bends inside pt later in the day (b)(6) 2015.Attempted removal of suprapubic catheter (b)(6) 2015, resulted in only 1 inch of catheter that had been inside the pt, still attached to plate when the exterior plate was lifted from the pt.Fractured-off remaining 7 inches of suprapubic catheter remained in pt's abdominal cavity and bladder.Pt went to er (b)(6) 2015 where x-rays confirmed presence and location of fractured-off sp catheter.Surgery performed (b)(6) 2015, to remove fractured-off suprapubic catheter from pt's abdominal cavity and bladder.

• Brand Name: BD BONANNO SUPRAPUBIC CATHETER
• Type of Device: BD BONANNO SUPRAPUBIC CATHETER
• Manufacturer (Section D): BECTON-DICKINSON
• MDR Report Key: 5563043
• MDR Text Key: 42309628
• Report Number: MW5061560
• Device Sequence Number: 1
• Product Code: GCY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 408289
• Device Catalogue Number: 408289
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 67