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

Model Number N/A

Device Problems Material Frayed (1262); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.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 during catheter insertion, the catheter was found difficult to insert.After removal, the wire and catheter were found deformed.

Event Description

It was reported that during catheter insertion, the catheter was found difficult to insert.After removal, the wire and catheter were found deformed.

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 a damaged guidewire is confirmed.One 0.038 in.¿j¿-tip guidewire in a plastic hoop and one 18 g introducer needle were returned for evaluation.An initial visual observation showed use residue on the returned samples.The guidewire was found to be stuck within the introducer needle with about 1 cm of the distal end of the guidewire protruding from the distal tip of the needle.The coiled wire of the guidewire was observed to be slightly unraveled proximal to the needle hub, and the core wire was found to be broken.A microscopic observation revealed the bevel of the needle was damaged.Once the guidewire was forcibly removed from the needle, a relatively large amount of biological residue was observed on the section of the guidewire that was stuck within the needle cannula, which may have contributed to the two components to becoming stuck.Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.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.

• Brand Name: FLEXXICON DIALYSIS CATHETER KIT 11F X 15CM (SHORT-TERM) (DUAL-LUMEN)
• Type of Device: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10432785
• MDR Text Key: 204048978
• Report Number: 3006260740-2020-02964
• Device Sequence Number: 1
• Product Code: LFJ
• UDI-Device Identifier: 00801741066108
• UDI-Public: (01)00801741066108
• Combination Product (y/n): N
• PMA/PMN Number: K881743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• 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: 5678150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Event Location: Hospital
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1