MAUDE Adverse Event Report: C. R. BARD, INC. CHANNEL DRAIN; CATHETER, IRRIGATION

Model Number	072234
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Status post sternotomy, coronary artery bypass grafting x2, a pleural effusion was drained on the right chest and 2 24 fr mediastinal blakes were placed anterior and posterior.On arrival from or to icu, intesive care unit regsitered nurse (icu rn) noted the leak in one of the two drains, rn thought it was the bulb, replaced the bulb, leak continued surgeon aware and exchanged the channel tubing, small crack found in tubing.No harm to patient from this event.

• Brand Name: CHANNEL DRAIN
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): C. R. BARD, INC.; 1625 w. 3rd st.; tempe AZ 12804
• MDR Report Key: 19391314
• Report Number: 19391314
• Device Sequence Number: 6776348
• Product Code: GBX
• UDI-Device Identifier: 00801741049927
• UDI-Public: (01)00801741049927(17)280731(10)NGHV2783
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/31/2024
• Report Date (Section F): 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 072234
• Device Catalogue Number: 072234
• Device Lot Number: NGHV2783
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/31/2024