MAUDE Adverse Event Report: C. R. BARD, INC. BARD (NOVAPLUS) 1/8 CWS CLOSED WOUND SUCTION KIT; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NON POWERED

Catalog Number V0043610

Device Problem Malposition of Device (2616)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/31/2019

Event Type  Injury  

Event Description

Pt was post-op day 2.Reported by ortho that when they removed pt's hemovac, tip of hemovac catheter is suspected to be still retained in the knee.Removed the next day.Fda safety report id# (b)(4).

• Brand Name: BARD (NOVAPLUS) 1/8 CWS CLOSED WOUND SUCTION KIT
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NON POWERED
• Manufacturer (Section D): C. R. BARD, INC. ; franklin lakes NJ 07417
• MDR Report Key: 8922286
• MDR Text Key: 155471248
• Report Number: MW5089233
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V0043610
• Device Lot Number: NGDP3873
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 89