MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number IPN033036

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the tunneler cannot be tightly connected to the catheter connection end (red buckle) during operation".No patient harm was reported.The patient's condition is reported as fine.

Event Description

It was reported "the tunneler cannot be tightly connected to the catheter connection end (red buckle) during operation".No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4), the customer returned one tunneler and the proximal end of the catheter body for analysis.Potential signs-of-use was observed within the catheter body.Visual analysis revealed that the tunneling instrument was slightly bent at the distal tip (portion that fits into catheter).Microscopic examination confirmed the bend and revealed scratch marks at the offset.This offset allows the tunneler to secure itself to the catheter body.Examination of the inside of the proximal end of the catheter revealed damage to the lip on which the tunneler would have been inserted.The appearance of the damage looks as if the customer applied undue force on the tunneler after inserting.This resulted in the lip within the catheter to become damaged and disconnect.Therefore, undue force likely caused or contributed to this event.Per measurement d in the tunneling graphic c-70019-001 rev02, the outer diameter of the tunneling instrument at the distal tip measured.0765", which is within the specification limits of.076"-.078".The inner diameter of the proximal end of the catheter body could not be accurately measured as the damage to the catheter tip partially occluded the opening.The returned tunneler was inserted through the proximal end of the catheter body.The tunnler was able to be easily removed and would not remain secure within the catheter body when undue force was applied, which is not the intended function of the device.Performed per ifu statement, "securely attach red connector of catheter to tunneler tip.Ensure parts are securely snapped together before pulling catheter through tunnel tract.Remove catheter clamp".A device history record review was performed with no evidence to suggest a manufacturing related cause.The ifu provided with this kit provides the following warnings, cautions and instructions for the user: "do not tunnel through muscle." "do not forcefully pull tunneler and catheter apart; catheter breakage may occur." "do not pull tunneler out of the venous insertion site on an angle; pull parallel to the body." "securely attach red connector of catheter to tunneler tip.Ensure parts are securely snapped together before pulling catheter through tunnel tract.Remove catheter clamp." "slide threaded compression cap and compression sleeve (pre-loaded on tunneler handle) onto catheter and beyond cut mark." the reported complaint of tunneler/catheter disconnecting was confirmed through examination of the returned sample.Visual analysis revealed scratch marks and bending at the distal end of the tunneling device.Subsequent damage was also observed inside the proximal opening of the catheter body.Despite this, the sample met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the report from the customer and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11440313
• MDR Text Key: 243146876
• Report Number: 9680794-2021-00088
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801902096333
• UDI-Public: 00801902096333
• Combination Product (y/n): N
• PMA/PMN Number: K111117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2023
• Device Model Number: IPN033036
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 13F20F0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1