MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR/BARD ACCESS SYSTEM 10 F LOENARD CATHETER; GROSHONG CATHETER SHORT TERM

Model Number 0600634

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Split (2537)

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

Event Date 11/02/2016

Event Type  Other  

Event Description

On (b)(6) 2016 4w rn went to flush the groshong catheter and bloody fluid started to spurt out of the pig tail.The rn inspected the catheter and there was a 1/4 inch slit in the pigtail.The catheter reference #0600634.A product complaint was completed and submitted to bard access systems.(b)(4).Unknown date of insertion.Product discarded.Second incident occured on (b)(6) 2016.An 4w rn went to flush the red capped port of the groshong catheter and there was a small hole in the catheter just below the larger part of the lumen of the pigtail.The groshong catheter was inserted (b)(6) 2016.The patient required interventional radiology to replace the groshong catheter.A product complaint was reported and logged under (b)(4).The manufacture requested return of the product.The product will be returned to the manufacturer.

• Brand Name: 10 F LOENARD CATHETER
• Type of Device: GROSHONG CATHETER SHORT TERM
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR/BARD ACCESS SYSTEM
• MDR Report Key: 6282837
• MDR Text Key: 66080137
• Report Number: MW5067505
• Device Sequence Number: 2
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/04/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 0600634
• Device Catalogue Number: 0600634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other