MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA SLIM-CATH DIALYSIS CATHETER 12F X 12.5CM (PRE-CURVED) (SHORT-TERM) (DUAL; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problems Material Frayed (1262); Physical Resistance/Sticking (4012)

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

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

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 a stuck guidewire is confirmed and appears to be related to the use of the device.The returned samples were a dialysis catheter with stylet, one dulator dilator, guidewire and hoop, and one introducer needle.The guidewire was returned through the introducer needle with the ¿j¿ tip extending from the distal end.Usage residue was observed on the guidewire and needle.Microscopic observation of the needle bevel revealed material deformation that appeared to have been caused due to contact with the guidewire.The product ifu cautions, ¿caution: do not pull back guidewire over the needle bevel as this may sever the end of the guidewire.The introducer needle must be removed first.¿ tensile force was applied at the proximal end of the guidewire and the guidewire was observed to retract elastically.This is indicative of the core wire being severed.The guidewire was removed from the distal end of the needle and resistance was felt due to the presence of dried usage residue between the guidewire and needle.The outer diameter of the guidewire was measured and found to be within specification.The guidewire was observed to have a frayed core wire.The distal weld tip of the guidewire was present.Since the cause of the stuck guidewire appears to be related to the use of the device, the complaint is confirmed.A lot history review (lhr) of rebx0150 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the guide wire was stuck after it entered the puncture needle during the surgery.On 12/26/2018, returned guidewire was found to be frayed.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER 12F X 12.5CM (PRE-CURVED) (SHORT-TERM) (DUAL
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8250304
• MDR Text Key: 133196564
• Report Number: 3006260740-2018-03887
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045387
• UDI-Public: (01)00801741045387
• Combination Product (y/n): N
• PMA/PMN Number: K010778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5554120
• Device Lot Number: REBX0150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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 Age: 62 YR