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

Model Number	0070430
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A 7mm flat drain was opened, it had loose plastic pieces along the end of it, 2 additional drains were opened.The first had the same plastic pieces loose, the third drain was placed in the patient.All drains were opened that way on to the sterile field.No harm to patient.

• Brand Name: SILICONE FLAT DRAIN
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): C. R. BARD, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 20891675
• Report Number: 20891675
• Device Sequence Number: 18376193
• Product Code: GBX
• UDI-Device Identifier: 00801741090752
• UDI-Public: (01)00801741090752
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/04/2024
• Report Date (Section F): 12/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: 0070430
• Device Catalogue Number: 0070430
• Device Lot Number: NGJV3183
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Date Report Sent to FDA: 12/04/2024