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

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2022

Event Type  malfunction  

Event Description

Hemovac drain tubing became loose and disconnected.Upon reconnecting, tubing became loose again and disconnected.Fda safety report id # (b)(4).

• Brand Name: DAVOL CLOSED WOUND SUCTION EVACUATOR
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 14074569
• MDR Text Key: 289091804
• Report Number: MW5108872
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female