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

Catalog Number	CS-15192-VFE
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "on (b)(6) 2024, the lure hub/fitting has a crack during use on the patient.They inserted the catheter on (b)(6) 2024.No harm for the patient." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "on (b)(6) 2024, the lure hub/fitting has a crack during use on the patient.They inserted the catheter on (b)(6) 2024.No harm for the patient." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one, opened retrograde hemodialysis kit including one connector assembly for analysis.Review of the bill of materials for this product revealed the returned connector assembly does not match the connector assembly found in this kit.The returned connector assembly has a red arterial luer hub and blue venous luer hub while the connector assembly in the kit reported by the customer has white luer hubs.Therefore, the customer either returned the incorrect device or reported the incorrect material.Visual analysis revealed scratch/stress markings on both the blue venous luer hub and red arterial luer hub.Cracks and fractures were observed on the red luer hub.The appearance of this damage is consistent with overtightening or repeated tightening of the hubs.No defects or anomalies were observed.Both luer connections were functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "flush each catheter lumen with sterile normal saline for injection, to establish patency and prime lumen(s) and flush the irrigation tube." a lab inventory syringe filled with water was used to flush each extension line.The blue venous luer connection flushed as intended without signs of leaking.The red arterial luer hub leaked from the cracks when flushed.A manual tug test confirmed both luer hub were securely attached to their respective lumens.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user , "examine catheter and extension lines before and after each treatment for any signs of damage.Repeated over tightening of bloodlines , syringes and caps will reduce connector life and could lead to potential connector failure." the report of a cracked luer hub was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the blue venous luer hub contained a crack and damage consistent with overtightening or repeated tightening of the hub.However, the returned device does not match what comes in product code cs-15192-vfe, which suggests the customer either returned the incorrect device or reported the incorrect material.A device history record review was performed on the reported material, and no relevant findings were identified.Based on the customer report and the sample received, the probable root cause cannot be determined without the reported device returned.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
• Common Device Name: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20416154
• Report Number: 9680794-2024-00982
• Device Sequence Number: 12814451
• Product Code: MSD
• UDI-Device Identifier: 10801902127171
• UDI-Public: (01)10801902127171(11)230628(17)260531(10)33F23E0776(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 33F23E0776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown