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

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

Provider went to remove drain and it had already fallen apart at the y connector.Drain pieces collected and given to risk management.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: 14074582
• MDR Text Key: 289088640
• Report Number: MW5108873
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male