MAUDE Adverse Event Report: C. R. BARD, INC. BARD / DAVOL; SILICONE ROUND DRAIN - MEDIUM 1/8", 49" LONG

Model Number REF# 0070310

Device Problems Difficult to Remove (1528); Tip breakage (1638)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/27/2017

Event Type  Injury  

Event Description

Product had l3-s1 posterior segmental in stimulation and decompression procedure on (b)(6) 2017; a silicone round drain was placed, jp drain.On removal, in preparation for inpatient discharge, the nurse observed resistance felt stuck and then released.On removal inspection, an end of tube was jagged.Physician immediately notified.Ct confirmed soft tissue drainage catheter piece in laminectomy bed.Pt returned to surgery for retained device removal on (b)(6) 2017.

• Brand Name: BARD / DAVOL
• Type of Device: SILICONE ROUND DRAIN - MEDIUM 1/8", 49" LONG
• Manufacturer (Section D): C. R. BARD, INC.; covington GA 30014
• MDR Report Key: 6962365
• MDR Text Key: 89814882
• Report Number: 6962365
• Device Sequence Number: 1
• Product Code: GBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF# 0070310
• 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: 10/05/2017
• Distributor Facility Aware Date: 09/27/2017
• Device Age: NA
• Event Location: Hospital
• 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): Required Intervention
• Patient Age: 78 YR