MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-L 15 FR X 31 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Model Number IPN001179

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 05/22/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that: it was reported that: the catheter was dysfunctional.The extension lines (artery + vein lines) kept folding (sticking together) despite clamps being opened.As soon as the dialysis machine was set into lines suction mode, the lines folded (stick together) at the level of the clamp.The catheter became inoperative and led to the loss of a blood circuit and a low dialysis.Additional information has been requested from the account.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "examine catheter and extension lines before and after each treatment for any signs of damage".The ifu also states, "do not clamp tubing repeatedly in the same place.Doing so may weaken the tubing".The ifu also states, "avoid clamping near luer-lock fittings".A device history record review was performed based on a potential lot from sales history, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: it was reported that: the catheter was dysfunctional.The extension lines (artery + vein lines) kept folding (sticking together) despite clamps being opened.As soon as the dialysis machine was set into lines suction mode, the lines folded (stick together) at the level of the clamp.The catheter became inoperative and led to the loss of a blood circuit and a low dialysis.Additional information has been requested from the account.

• Brand Name: HEMODIALYSIS SET: 2-L 15 FR X 31 CM RETR
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17161016
• MDR Text Key: 318010074
• Report Number: 9680794-2023-00422
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN001179
• Device Catalogue Number: CS-15312-VFE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED