MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problems Material Frayed (1262); Stretched (1601)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of recq0077 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported an elongation of the guide during the 2nd expansion.No other information provided.

Manufacturer Narrative

H11:section a through f - 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 following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an elongated/unraveled guidewire is confirmed and appears to be related to the use of the device.One 70 cm guidewire was returned for investigation.Red use residue was present throughout the sample.The core wire was observed to be frayed and the coil wire was elongated.A product label was returned with lot: recq0077.Microscopic observation of the frayed core wire revealed it to be slight narrowed.The distal weld tip was intact.The proximal end of the wire was able to be passed through a non-complainant introducer needle.The outer diameter of the guidewire was measured in a location that was not elongated and was found to be within specification.The characteristics of the core wire break and core wire elongation suggest the guidewire frayed due to excessive tensile forces.The product instructions for use (ifu) cautions, "caution: do not pull back guidewire over needle bevel as this may sever the end of the guidewire.The introducer needle must be removed first.Also, if unusual resistance is met during manipulation of the guidewire, discontinue the procedure and determine the cause of resistance before proceeding.Withdraw needle and guidewire if cause of resistance cannot be determined." a lot history review (lhr) of recq0077 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported an elongation of the guide during the 2nd expansion.No other information provided.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (SHORT-TERM) (DUAL-LUMEN)
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8946543
• MDR Text Key: 156111811
• Report Number: 3006260740-2019-02524
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045561
• UDI-Public: (01)00801741045561
• Combination Product (y/n): N
• PMA/PMN Number: K030268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• 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: 5593150
• Device Lot Number: RECQ0077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Event Location: Hospital
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1