MAUDE Adverse Event Report: C.R. BARD, INC. RELIAVAC; INSTRUMENT, SURGICAL, DISPOSABLE

Device Problem Break (1069)

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

Event Date 05/12/2019

Event Type  Injury  

Event Description

Patient underwent a right total hip arthroplasty revision.Two days post surgery an attempt was made to remove the drain that was placed.Upon attempting to remove the drain, the drain broke off leaving a retained portion of drain in the patient's hip.The patient required surgical intervention to remove the retained piece of drain.

• Brand Name: RELIAVAC
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial boulevard; covington GA 30014
• MDR Report Key: 8707252
• MDR Text Key: 148283485
• Report Number: 8707252
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/04/2019,05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31755 DA
• Patient Weight: 86