MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA SLIM-CATH 15CM PC JAPAN KIT; NIAGARA NON-IMPLANTED BLOOD ACCESS DEVICE

Catalog Number 5504150

Device Problem Kinked (1339)

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

Event Date 10/03/2016

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, at this time, for evaluation.A lot history review (lhr) of rezg0786 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the guide wire was not easy to be used because it was found kinked when it used for the procedure.

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 following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of insertion difficulty between the guidewire and stylet was confirmed but the exact cause remained unknown.The product returned for evaluation was a 0.038¿ x 70cm stainless steel guidewire.The wire was returned inlaid within what appeared to be the clear stiffening niagara stylet.The wire was bent in several locations proximal of the stylet luer and was bent in three locations within the clear stylet, just distal of the luer.The stylet was unremarkable to gross visual evaluation.Blood residue was seen within the stylet indicating use.An attempt to functionally advance the guidewire revealed excessive force was required to further advance the wire.Advancement of a non-complainant guidewire was unremarkable and advancement of the complainant wire was unremarkable up until the point of the observed bends in the wire.The wire was then withdrawn and examined by microscope.No disjoining of coils, or hard kinks in the wire, were observed.The wire and stylet were both measured to be within specification and no obvious manufacture caused damage, defect, or deformity was observed.It was apparent that the bends in the wire were the cause of insertion difficulty, but the timing of, and location where, the bends were introduced was unknown and consequently the cause was ultimately unknown.The bends in the wire could have been introduced at the time of use or were preexisting.No evidence was observed which could conclusively determine which was the case.

Event Description

It was reported that the guide wire was not easy to be used because it was found kinked when it used for the procedure.

• Brand Name: NIAGARA SLIM-CATH 15CM PC JAPAN KIT
• 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: 6529804
• MDR Text Key: 74162286
• Report Number: 3006260740-2017-00538
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045332
• UDI-Public: (01)00801741045332(17)200728(10)REZG0786
• 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,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: 5504150
• Device Lot Number: REZG0786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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