MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN919469
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "there was a previous incident on (b)(6), in which the arterial lumen ruptured near the cannula of a catheter of the same model, placed in the left jugular vein of another patient on (b)(6).In that case, there was also no associated traction.The situation was not formally reported at the time, and manipulation was considered as the cause, although this was not confirmed.At the time of this incident, batch: 71f24h0598 was available in the service.This is an intensive care unit with extensive experience in performing continuous dialysis techniques and such events are uncommon.The repetition of occurrences with similar characteristics raised concerns about the possibility of a structural failure associated with the model of catheter used." there was no patient's harm or injury as the patient was already in critical condition.There was a delay to therapy due to a new hemodialysis catheter needing to be inserted.
Additional Manufacturer Narrative
(b)(4).Upon discussion with the sales rep it was discovered that this event is a duplicate of a previously reported event, which was submitted under mdr#3006425876-2025-01094 on 21-nov-2025; therefore, this report will be retracted.
Event or Problem Description
It was reported that "there was a previous incident on 24/09, in which the arterial lumen ruptured near the cannula of a catheter of the same model, placed in the left jugular vein of another patient on 22/09.In that case, there was also no associated traction.The situation was not formally reported at the time, and manipulation was considered as the cause, although this was not confirmed.At the time of this incident, batch 71f24h0598 was available in the service.This is an intensive care unit with extensive experience in performing continuous dialysis techniques and such events are uncommon.The repetition of occurrences with similar characteristics raised concerns about the possibility of a structural failure associated with the model of catheter used." there was no patient's harm or injury as the patient was already in critical condition.There was a delay to therapy due to a new hemodialysis catheter needing to be inserted.Associated mdr number includes : 3006425876-2025-01141 and 3006425876-2025-01140.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 23777640
• Report Number: 3006425876-2025-01140
• Device Sequence Number: 18674890
• Product Code: FOZ
• UDI-Device Identifier: 10801902219203
• UDI-Public: (01)10801902219203(11)250826(17)300731(10)71F25H0830(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K970864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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 Model Number: IPN919469
• Device Catalogue Number: CV-12123-F
• Device Lot Number: 71F25H0830
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2025
• 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; NOT REPORTED
• Patient Sex: Unknown