MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD PROBE COVER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The information provided by bd 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 bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the employee noticed he had gel all over his hands post procedure.It was stated "the probe cover most likely had a hole in it ".No other information was provided.

• Brand Name: BARD PROBE COVER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• 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: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 9679562
• MDR Text Key: 193971233
• Report Number: 3006260740-2020-00413
• 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: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/17/2020
• 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