MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN SITE RITE PROBE COVER; ULTRASOUND TRANSDUCER AND ACCESSORIES

Catalog Number UNKNOWN

Device Problems Hole In Material (1293); Device Contamination with Body Fluid (2317)

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

Event Type  malfunction  

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) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

On (b)(6) 2016 - facility reported that their is blood residue on the inside of the probe covers.No other information was provided.On (b)(6) 2016 - complainant stated that during surgery the physician was using the probe cover on the patient.They removed probe cover and physician noticed blood residue on the inside.Healthcare professional alleged a hole in the cover.On (b)(6) 2016 - facility reports the probe cover was used on a geiger counter hand piece which was used during a breast node surgery.They state "there was nothing prior to use" in response to our question asking if the patient had any bleeding prior to the procedure that may have transferred to the probe cover.The facility confirms the surgery was an open case.

• Brand Name: UNKNOWN SITE RITE PROBE COVER
• Type of Device: ULTRASOUND TRANSDUCER AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 6055061
• MDR Text Key: 58712845
• Report Number: 3006260740-2016-00560
• 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: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization