MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Model Number IPN919796

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: the line was stitched in - it slipped through the holder,(associated (b)(4)) happened twice on 1 patient (associated to (b)(4)), there was an issue the week before, (associated this complaint).The patient's condition did not deteriorate due to immediate replacement of line, the patient was not harmed.

Event Description

It was reported that: the line was stitched in - it slipped through the holder,(associated (b)(6)) happened twice on 1 patient (associated to (b)(6)), there was an issue the week before, (associated this complaint) the patient's condition did not deteriorate due to immediate replacement of line, the patient was not harmed.

Manufacturer Narrative

(b)(4).The customer returned one unopened acute hemodialysis set for analysis.This kit is assumed to be a representative sample.The kit was opened to further inspect the components.Visual analysis revealed that the catheter wing clip was secure to the catheter body and could not be easily separated.No other defects or anomalies were observed on the returned juncture hub nor on the wing clip.Visual inspection of the actual device could not be performed as it was not returned for evaluation.Force was applied to the catheter wing clip to determine whether it could be easily removed.The wing clip was observed to be fixed in place and was not able to be removed.Functional inspection of the actual device could not be performed as it was not returned for evaluation.A device history record review was performed, and no relevant findings were identified.The customer report of a catheter migration could not be confirmed through complaint investigation of the returned sample.Inspection of the returned representative catheter revealed no obvious anomalies or defects.The suture wing clip was observed to be secure.A device history record review was performed with no evidence to suggest a manufacturing related root cause.Based on these circumstances, and without the actual sample returned for analysis, the probable root cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17955734
• MDR Text Key: 325903566
• Report Number: 3006425876-2023-00985
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100221
• UDI-Public: 00801902100221
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IPN919796
• Device Catalogue Number: CS-25142-F
• Device Lot Number: 71F23F0934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2023
• 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.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female