MAUDE Adverse Event Report: C. R. BARD, INC. CLOSED WOUND SUCTION; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	0043600
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device found leaking at the y port.

• Brand Name: CLOSED WOUND SUCTION
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 15592600
• Report Number: 15592600
• Device Sequence Number: 14035420
• Product Code: GCY
• UDI-Device Identifier: 00801741049347
• UDI-Public: 00801741049347
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2022
• Report Date (Section F): 09/29/2022

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: 0043600
• Device Catalogue Number: 0043600
• Device Lot Number: 048132-0 951R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 09/29/2022