MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA SLIM-CATH STRAIGHT DUAL-LUMEN DIALYSIS KIT 12F X24CM (EXPORT ONLY); NIAGARA NON-IMPLANTED BLOOD ACCESS DEVICE

Catalog Number 5503240

Device Problem Kinked (1339)

Patient Problem No Information (3190)

Event Date 01/05/2016

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 at (b)(4) due to the expire of stock period after visual inspection.A lot history review (lhr) of rezg0257 showed no other similar product complaint(s) from this lot number.Discarded at (b)(4) due to the expire of stock period after visual inspection.

Event Description

It was reported that the operator could not advance catheter along the guidewire.The operator confirmed that the guidewire was kinked.

• Brand Name: NIAGARA SLIM-CATH STRAIGHT DUAL-LUMEN DIALYSIS KIT 12F X24CM (EXPORT ONLY)
• Type of Device: NIAGARA NON-IMPLANTED BLOOD ACCESS DEVICE
• 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 6713788
• MDR Text Key: 80275004
• Report Number: 3006260740-2017-01044
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045325
• UDI-Public: (01)00801741045325(10)REZG0257
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K010778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5503240
• Device Lot Number: REZG0257
• 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
• Date Device Manufactured: 07/01/2015
• 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