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 Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

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 manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of recx3106 showed no other similar product complaint(s) from this lot number.

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.On (b)(6) 2020- returned guidewire was frayed.

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.(b)(6)2020 - returned guidewire was frayed.

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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed, but the exact cause could not be determined.One open kit for a flexxicon dialysis catheter was returned for investigation.The guidewire was received in its hoop.The catheter and introducer needle were not returned for investigation.The distal end of the guidewire was extending from the hoop and it was observed that the coil wire was stretched over the core wires.The two core wires and elongated coil wire terminated within 3mm of each other.A microscopic examination of the coil wire revealed a striated and lustrous surface, which is consistent with the wire being severed by a sharp instrument.The weld tip was missing from the distal end of the guidewire.The length of the longest core wire was 67.3cm, which indicates that approximately 3cm of the core wire was removed from the distal end of the guidewire.It appeared that the wires were cut after the coil wire was stretched and elongated over the core wires.The guidewire and kinked and bent.A functional test revealed that the proximal end of the guidewire was passed through an unused introducer needle without any resistance.Since the distal end of the guidewire, the catheter, and introducer needle were not returned, the cause of the complaint could not be determined.It is possible that the wire was damaged during the insertion procedure.No defects associated with the manufacturing process were observed on the returned sample.A lot history review (lhr) of recx3106 showed no other similar product complaint(s) from this lot number.

• 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: 9768850
• MDR Text Key: 194152052
• Report Number: 3006260740-2020-00674
• 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: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• 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
• Device Lot Number: RECX3106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1