MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FLEXXICON KIT 11F X 15CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty inserting a guidewire is confirmed and was determined to be use related.Four 18 g introducer needles (two with round hubs and two with square hubs), three 0.038 in.¿j¿-tip guidewires (two returned in plastic hoops), two iv catheters with round hubs, three 12 fr dualator dilators, and one 15 cm flexxicon catheter were returned for evaluation.An initial visual observation showed use residue on most of the samples.One of the introducer needles with a square hub was observed to be stuck on the guidewire that was returned without a plastic hoop.The coiled wire at the distal end of this guidewire was observed to be unraveled and the core wire could be seen to be broken.Once this guidewire was removed from the introducer needle, a large amount of biological residue was observed on the section of the guidewire that was within the needle cannula.A microscopic observation revealed the bevel of both of the introducer needles with square hubs were damaged.The break site of the core wire of the broken guidewire was observed to be tapered with a flat and granular fracture surface.The damage observed on the bevel of the introducer needles suggests the guidewires may have been retracted while still within the needle cannula which caused difficulties in inserting the guidewire.The features of the fracture in the core wire of the broken guidewire are characteristic of excessive tensile (pulling) force.Also, the amount and location of biological material on the broken guidewire may have contributed to the break in the guidewire as retraction of the wire together with the biological material could have caused the pieces to become stuck.The product ifu cautions: ¿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) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the guidewire could not be advanced during the guidewire was inserted into the introducer needle.The doctor checked the removed guidewire and found that the guidewire was damaged.Therefore, the second kit was opened and used for the procedure.However, because the guidewire could not be advanced again during the guidewire insertion procedure, the second guidewire was removed.When the third kit was opened and the guidewire was inserted, the guidewire could be advanced without problems and the placement procedure was completed.There was no reported patient injury.11/22/2019 - the two wires returned were broken.This report addresses the second wire.

• Brand Name: FLEXXICON KIT 11F 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
• 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: 9455569
• MDR Text Key: 170743102
• Report Number: 3006260740-2019-03823
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741075049
• UDI-Public: (01)00801741075049
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: 801(E)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5577150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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