MAUDE Adverse Event Report: C. R. BARD, INC. NOVAPLUS CWA 400 CLOSED WOUND SUCTION KIT; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number V0043610

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/05/2021

Event Type  malfunction  

Event Description

Patient underwent a total knee replacement few days back.A bard hemovac drain was placed in the wound to facilitate drainage.On day of discharge, the rn went to remove the drain and met some resistance but was able to pull the drain.However, upon inspection of the drain post removal, he found the drain to be incomplete in length.An x-ray was taken and found a portion of the drain had broken off inside the operative site and was retained.Couple of days later, the patient was taken back to surgery for removal of the retained portion.The retained drain piece measured 4 x 0.2 x 0.2 cm in length.Patient will be monitored for possible post-op infection.

• Brand Name: NOVAPLUS CWA 400 CLOSED WOUND SUCTION KIT
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12998655
• MDR Text Key: 282193689
• Report Number: 12998655
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/10/2021

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
• Device Operator: Health Professional
• Device Model Number: V0043610
• Device Catalogue Number: V0043610
• Device Lot Number: NGFV0826
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20805 DA
• Patient Sex: Male
• Patient Weight: 267 KG
• Patient Race: White