MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. STERILE SITE RITE U/S COVER; TRANSDUCER ULTRASONIC DIAGNOSTIC

Model Number 900013B01

Device Problems Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)

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

Event Date 09/30/2019

Event Type  malfunction  

Event Description

Some of the sterile site rite covers have tiny pin holes in the top.These are used in sterile procedures.The u/s transducer underneath is not sterile, therefore if the pin holes are not seen, we could be compromising the sterility of the procedure.We are only having issues with one lot.Fda safety report id# (b)(4).

• Brand Name: STERILE SITE RITE U/S COVER
• Type of Device: TRANSDUCER ULTRASONIC DIAGNOSTIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 9156556
• MDR Text Key: 161413770
• Report Number: MW5090220
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900013B01
• Device Catalogue Number: 900013B01
• Device Lot Number: REDSO103
• 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