MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HEMOVAC 10 FR. DRAIN; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE NONPOWERED

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2018

Event Type  malfunction  

Event Description

Patient underwent a bedside lumbar drain removal complicated by a retained piece of fractured catheter, which required surgical removal.Fractured retained catheter was in the fascia.

• Brand Name: HEMOVAC 10 FR. DRAIN
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE NONPOWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.
• MDR Report Key: 8403494
• MDR Text Key: 138406140
• Report Number: MW5084755
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/05/2019

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR