MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CU-25122-F
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Sleepiness/Drowsiness/Somnolence (4850)
Date of Event	03/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: " the patient developed an allergy-like condition (drowsiness and malaise) after insertion of the device with a product coating".The patient was reported as fine after the incident with no other reported harm or consequence.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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, "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine , silver sulfadiazine, and/or sulfa drugs.Remove catheter immediately if adverse reactions occur after catheter placement.Note: perform sensitivity testing to confirm allergy to catheter antimicrobial agents, if adverse reaction occurs.".The complaint of catheter related allergic reaction could not be confirmed.No sample was returned for investigation.The customer did not report that allergy testing was performed to confirm a chlorhexidine allergy.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related issue.Therefore, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: " the patient developed an allergy-like condition (drowsiness and malaise) after insertion of the device with a product coating".The patient was reported as fine after the incident with no other reported harm or consequence.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 19284606
• Report Number: 3006425876-2024-00455
• Device Sequence Number: 20737109
• Product Code: DQY
• UDI-Device Identifier: 00801902100276
• UDI-Public: 00801902100276
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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 Expiration Date: 08/23/2025
• Device Catalogue Number: CU-25122-F
• Device Lot Number: 71F23J0478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• 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
• Patient Sex: Unknown