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 Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported an incident is reported due to a possible structural failure of a medical device, with spontaneous disconnection of the venous branch of a haemodialysis catheter, without any type of traction having occurred.The device in question was a 15 cm triple lumen haemodialysis catheter manufactured by arrow.The incident was identified during routine dressing of a patient undergoing continuous dialysis.Blood loss was observed and promptly controlled.The catheter was immediately replaced with a guide wire, without the patient suffering any clinical damage.Dialysis was temporarily suspended and resumed after the situation was resolved.The patient did not develop any signs or symptoms due to the event.Estimated blood loss was minimal as the procedure was stopped promptly.Associated mdr number includes: 3006425876-2025-01140.
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 # 3006425876-2025-01093 on 21-nov-2025; therefore, this report will be retracted.
Event or Problem Description
It was reported an incident is reported due to a possible structural failure of a medical device, with spontaneous disconnection of the venous branch of a haemodialysis catheter, without any type of traction having occurred.The device in question was a 15 cm triple lumen haemodialysis catheter manufactured by arrow.The incident was identified during routine dressing of a patient undergoing continuous dialysis.Blood loss was observed and promptly controlled.The catheter was immediately replaced with a guide wire, without the patient suffering any clinical damage.Dialysis was temporarily suspended and resumed after the situation was resolved.The patient did not develop any signs or symptoms due to the event.Estimated blood loss was minimal as the procedure was stopped promptly.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: 23777765
• Report Number: 3006425876-2025-01141
• Device Sequence Number: 15971476
• 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