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

Model Number	IPN919796
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only section d.4.-(udi)# corrected to (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.
Event or Problem 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 tc# 1900108107), 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.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM
• Common Device Name: 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17955734
• Report Number: 3006425876-2023-00985
• Device Sequence Number: 17903422
• Product Code: MPB
• UDI-Device Identifier: 00801902100221
• UDI-Public: (01)00801902100221(11)230619(17)250413(10)71F23F0934(21)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 11/13/2023; Not provided
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/14/2023; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female