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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional 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 guidewire stuck in an introducer needle is confirmed and was determined to be use related.One 0.035 in.J-tip guidewire in a plastic hoop and one 18 g introducer needle were returned for evaluation.An initial visual observation showed blood residue on the returned samples.About 1.7 cm of the guidewire was observed to be protruding from the distal tip of the introducer needle.The core wire was found to be broken during tactile evaluation of the guidewire.The guidewire was found to be stuck within the introducer needle.The guidewire was able to be pushed through the needle with considerable force.A microscopic observation of the introducer needle before and after the guidewire was removed revealed the bevel of the needle was damaged.A large amount of biological material was observed on the section of the guidewire that was within the cannula of introducer needle, which may have contributed to the guidewire becoming stuck as well as the break in the core wire.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) of redp4256 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the morning of (b)(6) the micu reported they tried to place a brevia temporary dialysis catheter and they had an issue with the guidewire and needle.Per the nurse report: unable to get needle off of guidewire after guidewire inserted.The needle was still in the patient and the physician was unable to pull the needle back, hence leaving the guidewire in the patient.They were able to place another catheter.No patient harm reported.On 8/23/2019 the returned wire was frayed.

• Brand Name: BREVIA DIALYSIS CATHETER KIT 11F (SHORT-TERM) (15CM)
• Common Device Name: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9039722
• Report Number: 3006260740-2019-02709
• Device Sequence Number: 2516441
• Product Code: LFJ
• UDI-Device Identifier: 00801741045424
• UDI-Public: (01)00801741045424
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K881743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5563150
• Device Lot Number: REDP4256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1