MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, SUBCLAVIAN

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2020

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, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a guidewire stuck in an introducer needle is confirmed and was determined to be use related.One 0.038 in.X 70 cm ¿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, and the guidewire was found to be stuck within the introducer needle.The core wire of the guidewire was found to be broken near the distal end of the guidewire during tactile evaluation.A microscopic observation revealed damage on the bevel of the introducer needle.Once the guidewire was removed from the introducer needle with a considerable amount of force, biological residue was observed on the section of the guidewire that was within the needle cannula.The break site at the distal end of the core wire of the guidewire was observed to be tapered with a mostly flat and granular fracture surface, which indicates tensile failure.The damage observed on the bevel of the introducer needle suggests the guidewire may have been retracted while still within the needle cannula which caused the guidewire to become stuck.The amount and location of biological material within the needle cannula may have also contributed to the guidewire becoming stuck within the introducer 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) of redw1323 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that guide wire stuck with pink needle.On (b)(6) 2020 - returned wire is broken.

• Brand Name: FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN)
• Type of Device: CATHETER, SUBCLAVIAN
• 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: 10313883
• MDR Text Key: 200056122
• Report Number: 3006260740-2020-02615
• Device Sequence Number: 1
• Product Code: LFJ
• UDI-Device Identifier: 00801741066122
• UDI-Public: (01)00801741066122
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K881743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 5678200
• Device Lot Number: REDW1323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Event Location: Hospital
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2019
• 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