MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITERITE ULTRASOUND SYSTEM PROBE COVER KIT WITH GEL

Catalog Number 9001C0197

Device Problem Hole In Material (1293)

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

Event Date 04/09/2018

Event Type  malfunction  

Event Description

Probe cover found to have 2 holes in bottom at end of surgical case.

• Brand Name: SITERITE ULTRASOUND SYSTEM PROBE COVER KIT WITH GEL
• Type of Device: PROBE COVER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; salt lake city UT 84116
• MDR Report Key: 7486226
• MDR Text Key: 107454498
• Report Number: MW5077010
• Device Sequence Number: 1
• Product Code: ITX
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 9001C0197
• Device Lot Number: REB20635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Age: 64 YR
• Patient Weight: 96