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

Lot Number 951R

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2022

Event Type  malfunction  

Event Description

Suction drain tube disconnected from suction device.Tube was then pulled from patient as planned prior to discharge.Fda safety report id # (b)(4).

• Brand Name: DAVOL CLOSED WOUND SUCTION EVACUATOR HEMOVAC
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): DAVOL / C.R. BARD INC.
• MDR Report Key: 14111460
• MDR Text Key: 289430811
• Report Number: MW5108979
• 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: 04/11/2022

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 Lot Number: 951R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2022
• Patient Sequence Number: 1
• Patient Age: 93 YR
• Patient Sex: Male