MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 21 GAUGE NEEDLE GUIDE KIT; ULTRASOUND TRANSDUCER AND ACCESSORIES

Catalog Number 900013B01

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

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) of reaz0361 showed (b)(4) other similar product complaint(s) from this lot number.The complaints for this lot number reaz0361 have been reported from the same facility.

Event Description

As reported by the facility, their infection control department had the vascular access team test a siterite probe cover after use to look for leaks.Facility tested a cover after use by filling it with water and reported finding a leak.This report references the fourth probe cover.

• Brand Name: 21 GAUGE NEEDLE GUIDE KIT
• 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: michael new ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225445
• MDR Report Key: 6431911
• MDR Text Key: 71105038
• Report Number: 3006260740-2017-00308
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741037771
• UDI-Public: (01)00801741037771(17)191130(10)REAZ0361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/24/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 900013B01
• Device Lot Number: REAZ0361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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): Life Threatening