MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45703-XP1A
Medical Device Problem Codes	Obstruction of Flow (2423); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a triple lumen catheter (tlc) was inserted, and the brown (distal) infusion port could not be flushed or aspirated.The remaining two lumens were reported to be functional.It was subsequently reported that the catheter was slightly malpositioned; however, the device remained partially functional.The catheter remains implanted in the patient, with instructions not to use the brown (distal) lumen.There were no reports of patient injury, harm, or adverse health consequences associated with the event.The patient's condition was reported as fine.The reporter indicated that a similar issue had occurred once previously over an eight-year period.Additionally, it was reported that the assisting resident stated similar events had occurred two other times during the same month, resulting in a total of three reported occurrences within one month involving the same device type.No patient injury or adverse health outcome was reported in association with this event.Good faith efforts were made to obtain additional information regarding the reported device issues, including confirmation of the multiple reported occurrences and assessment of any patient harm.Three documented attempts were made to contact the distributor; however, no response or additional information was received.Associated mdr include (specific event) and 9680794-2026-00381 (multiple events without additional details).
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ARROW PI CVC KIT: 3L 7 FR X 20 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25135935
• Report Number: 9680794-2026-00358
• Device Sequence Number: 9516560
• Product Code: FOZ
• UDI-Device Identifier: 20801902117216
• UDI-Public: (01)20801902117216(11)251126(17)270228(10)33F25L0093(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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 Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 33F25L0093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2025
• 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: NOT REPORTED.
• Patient Sex: Unknown