MAUDE Adverse Event Report: 3T MEDICAL SYSTEMS, INC. CONSTAVAC WITH QUICK DISCONNECT; APPARATUS, AUTOTRANSFUSION

Lot Number 855168008258

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 11/08/2019

Event Type  malfunction  

Event Description

Patient had a constavac placed during hip surgery, hardware removal and revision orif.Two days later rn attempted to remove the drain from the patient per md order.When pulling the drain rn heard a snap sound, the rest of the drain came out of the patient, on examination of the tip of the catheter there was a jagged edge.Md was notified.Retained drain seen on xray.Patient taken to operating room for removal of retained drain piece the following day.

• Brand Name: CONSTAVAC WITH QUICK DISCONNECT
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): 3T MEDICAL SYSTEMS, INC.; 41157 capital drive; canton MI 48187
• MDR Report Key: 9395166
• MDR Text Key: 168654451
• Report Number: 9395166
• Device Sequence Number: 1
• Product Code: CAC
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 855168008258
• 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: 11/21/2019
• Date Report to Manufacturer: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA