MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	CDC-21242-XCN1A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the mac was indwelling within the patient when the nurse pulled back on the lumen and had no blood return.When the nurse did get blood return, bubbles were observed.One hour later the nurse noticed wetness on the patient's skin.The nurse flushed the catheter and noticed swelling within the patient's neck.The decision was made to remove the catheter due to concern over possible infiltration and/or catheter damage".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer report of a catheter body leak could not be confirmed through investigation of the returned sample.The customer returned one sheath for analysis.Visual analysis of the sheath revealed no obvious defects or anomalies.The sheath passed all relevant dimensional and functional requirements including leak testing performed per relevant standard.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, no problem was found.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the mac was indwelling within the patient when the nurse pulled back on the lumen and had no blood return.When the nurse did get blood return, bubbles were observed.One hour later the nurse noticed wetness on the patient's skin.The nurse flushed the catheter and noticed swelling within the patient's neck.The decision was made to remove the catheter due to concern over possible infiltration and/or catheter damage".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• 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 27560
• MDR Report Key: 23896318
• Report Number: 9680794-2025-01056
• Device Sequence Number: 14607263
• Product Code: DYB
• UDI-Device Identifier: 10801902179286
• UDI-Public: (01)10801902179286(11)250207(17)260628(10)33F24L0158(21)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2026
• Device Catalogue Number: CDC-21242-XCN1A
• Device Lot Number: 33F24L0158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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: N/A.; N/A.
• Patient Sex: Unknown