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 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redu2364 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the guide wire could not be placed successfully during insertion, after removal, the guide wire was found deformed.On (b)(6) 2020 - during follow up, a photograph of the subject device was received, which shows an unraveled guidewire.

Event Description

It was reported that the guide wire could not be placed successfully during insertion, after removal, the guide wire was found deformed.(b)(6) 2020 - during follow up, a photograph of the subject device was received, which shows an unraveled guidewire.

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, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed, and the cause was determined to be use related.The products returned for evaluation were one 0.038 in.¿j¿-tip guidewire in a plastic hoop and one 18 g introducer needle.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.The returned product samples were evaluated and the guidewire was confirmed to be broken with the coil wire being unraveled.It appeared that the inner core wire had broken which allowed the outer coil wire surrounding it to unravel.Microscopic examination of the fracture sites revealed the following: shearing of the wire at the break which was indicative of direct contact with a hard-edged instrument (such as an introducer needle).Narrowing of the wire cross-section near the fracture site, which is a characteristic feature of a strong pull on the wire.Damage to the inside edge of the introducer needle which can occur if the guidewire is forcefully retracted against the needle, damaging the shape of the sharpened bevel.Biological material was also seen on the wire which may have contributed to the observed guidewire fracture as retraction of the wire together with the biological material could have caused the pieces to become 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.An examination of the wire structure revealed no potential damage/defect related to manufacture of the product.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 redu2364 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: 10218228
• MDR Text Key: 197329597
• Report Number: 3006260740-2020-02309
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 5678150
• Device Lot Number: REDU2364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Event Location: Hospital
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1