MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE PROBE COVER KIT WITH GEL (48 IN); TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Catalog Number	9001C0197
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rebz0635 showed no other similar product complaint(s) from this lot number.Mw5077010.
Event or Problem Description
It was reported that probe cover was found to have two holes in the bottom at the end of the surgical case.

• Brand Name: SITE~RITE PROBE COVER KIT WITH GEL (48 IN)
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7573794
• Report Number: 3006260740-2018-01230
• Device Sequence Number: 13521714
• Product Code: ITX
• UDI-Device Identifier: 00801741037801
• UDI-Public: (01)00801741037801
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2018
• Report Date (Section F): 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9001C0197
• Device Lot Number: REBZ0635
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/02/2018