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

Model Number 43610 10FR

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/05/2020

Event Type  malfunction  

Event Description

Right hip surgery completed.Hemovac drain tube placed.At removal, tube broke off leaving approx.4 inches inside patient.

• Brand Name: HEMOVAC 10 FR DRAIN
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC; 56 east bell drive; warsaw IN 46581
• MDR Report Key: 10167042
• MDR Text Key: 195553887
• Report Number: 10167042
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 43610 10FR
• 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: 06/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2020
• 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: 22995 DA
• Patient Weight: 47