MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN918813
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "involved 76-year-old patient admitted to intensive care for encephalopathy in the context of acute renal failure.The brown hub of the distal line ruptured during care.The right femoral central venous line was inserted on (b)(6) 2025.No direct consequences, as the line was clamped immediately." the patient's current condition is reported as "stable".
Additional Manufacturer Narrative
Qn (b)(4).
Additional Manufacturer Narrative
(b)(4) the customer provided two photos for analysis.The photos show an extension line with the luer hub separated.The extension line is clamped, as the luer hub is no longer connected.The customer also returned one 4-lumen catheter for analysis.Signs of use, in the form of biological material, were observed on the catheter body and within the extension lines.Visual analysis of the distal extension line revealed that the brown luer hub had separated and was not returned.Visual examination of the separated hub to evaluate the nature of the break could not be performed as it was not returned for evaluation.The total length of the distal extension line from the juncture hub to the point of separation measured 96mm, which is longer than the reference specification of 79mm per catheter product drawing.This suggests that the extension line material that is recessed with the luer hub was present with no evidence of tearing.Additionally, the customer photo does not appear to show any remnants of the extension line extrusion in the separated hub.The distal extension line outer diameter measured 2.14mm, which is within the specification limits of 2.13mm - 2.21mm per distal extension line extrusion product drawing.The distal extension line inner diameter measured 1.4224mm, which is within the specification limits of 1.42mm - 1.50mm per distal extension line extrusion product drawing.A manual tug test confirmed that the other extension lines were secure to their luer hubs.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, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the report of an extension line/luer hub separation was confirmed through complaint investigation of the returned sample.Visual analysis revealed the distal extension line had separated from the luer hub; however , the luer hub was not returned.The separation point on the extension line suggests the extension line material that is recessed within the luer hub was present, however, the nature of the break could not be confirmed without the separated hub returned.A device history record review was performed based and no relevant findings were identified.Based on the sample received and without the luer hub returned, the root cause cannot be determined.Teleflex will continue to monitor and trend complaints of this nature.
Event or Problem Description
It was reported "involved 76-year-old patient admitted to intensive care for encephalopathy in the context of acute renal failure.The brown hub of the distal line ruptured during care.The right femoral central venous line was inserted on (b)(6) 2025.No direct consequences, as the line was clamped immediately." the patient's current condition is reported as "stable".

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5 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: 21927839
• Report Number: 3006425876-2025-00406
• Device Sequence Number: 18305512
• Product Code: DQY
• UDI-Device Identifier: 00801902102171
• UDI-Public: (01)00801902102171(11)240620(17)281130(10)71F24F0635(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: IPN918813
• Device Catalogue Number: CS-15854-E
• Device Lot Number: 71F24F0635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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 Age: 76 YR
• Patient Sex: Unknown