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

Model Number	0043620
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
There have been 4 instances reported by staff of the hemovacs disconnecting while maneuvering patients.

• 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: 11929737
• Report Number: 11929737
• Device Sequence Number: 16953187
• Product Code: GCY
• UDI-Device Identifier: 00801741049361
• UDI-Public: (01)00801741049361
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/19/2021
• Report Date (Section F): 05/19/2021

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: 0043620
• Device Catalogue Number: 0043620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 54
• Date Report Sent to FDA: 05/19/2021