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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redu3444 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the resistance was experienced during guide wire insertion, after removal, the guide wire tip was found split and which cause the insertion failure.Use new device of 5678200.

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 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 damaged guidewire is confirmed and was determined to be use related.One 0.038 in.¿j¿-tip guidewire in a plastic hoop was returned for evaluation.An initial visual observation showed use residue on the returned sample.An ¿s¿-shaped bend was observed approximately 28.4 cm distal to the proximal end of the guidewire, and another more gradual and curved bend was observed approximately 30.2 cm distal to the proximal end of the guidewire.The core wire of the guidewire was observed to be intact during tactile evaluation.A microscopic observation revealed some slight kinking and separation of the coils of the coiled wire at the location of the ¿s¿-shaped bend.The shape and location of the bend in the guidewire, the amount of use residue on the returned sample, and the description of the event suggest the guidewire was damage during insertion and/or manipulation of the guidewire.The product ifu states: ¿if unusual resistance is met during manipulation of the guidewire, discontinue the procedure and determine the cause of resistance before proceeding.¿ a lot history review (lhr) of redu3444 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the resistance was experienced during guide wire insertion, after removal, the guide wire tip was found split and which cause the insertion failure.Use new device of 5678200.

• 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
• MDR Report Key: 10431858
• MDR Text Key: 203704911
• Report Number: 3006260740-2020-02961
• Device Sequence Number: 1
• Product Code: LFJ
• UDI-Device Identifier: 00801741066122
• UDI-Public: (01)00801741066122
• 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: 09/30/2020

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 Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 5678200
• Device Lot Number: REDU3444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Event Location: Hospital
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1