MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA APD 12 FRENCH J TUBE; TUBE, DRAINAGE, SUPRAPUBIC

Model Number M001271360

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Event Description

Patient had a right chest tube placed in ct scan department.The next day, it was discovered that the chest tube was disconnected and the nurse clamped the chest tube.Patient's vital signs were stable, no tachypnea, no hypoxia, hemodynamically stable.Stat chest x-ray ordered to assess positioning with results of dislodged tube.The chest tube was removed in interventional radiology later same day.Upon examination the tube was pulled apart where it had been attached to the hub (found to be separated at the distal lower lumbar back connection from the atrium per radiologist).During the procedure, the patient's respiratory status remained stable.Successful removal of right side chest tube.The tube and the hub were retained to be examined by the company to determine if there was any defect in the product.The patient had a chest x-ray and went back to room.It is unknown to writer at this time if tube will need to be replaced.The manufacturer representative was contacted about the event and availability of the chest tube for evaluation.

• Brand Name: FLEXIMA APD 12 FRENCH J TUBE
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11364857
• MDR Text Key: 233048221
• Report Number: 11364857
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M001271360
• Device Catalogue Number: M001271360
• Device Lot Number: 26500980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Weight: 97