MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN918515
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that damage to the product was discovered when unpacking the central venous catheter.A hole was found in the extension line (cs-15703-e; affected batch number 71f22m1612) during insertion, and one extension line (de-15853-kwen; affected batch number 71f24h1309) was found to be slit during preparation.A third catheter was used to resolve the issue.The patient had no harm or injury.The associated emdr report numbers are 3006425876-2025-00155.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided three images showing a cvc for analysis.Visual analysis confirmed what appears to be a leak on one of the extension lines.The also customer returned one, 3-lumen cvc for analysis.No obvious signs of use were observed.Visual analysis of the medial extension line revealed a hole adjacent to the juncture hub.Microscopic examination confirmed the damage and revealed that the edges were smooth and uniform.The appearance of the damage is consistent with damage resulting from contact with a sharp instrument (i.E.Scissors, scalpel, etc.).The location of the hole measured 19mm from the juncture hub.The medial extension line outer diameter measured 2.16mm, which is within the specification limits of 2.13mm-2.21mm per the medial extrusion product drawing.The medial extension line inner diameter measured 1.4478mm, which is within the specification limits of 1.42mm-1.50mm per the medial extrusion product drawing.A lab inventory syringe filled with water was attached to all three extension lines and flushed.When flushing the medial line, water was observed leaking from the hole.No leaks were noted when flushing the distal and proximal extension lines.Performed per ifu statement, "flush lumen(s) to completely clear blood from catheter".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "ensure catheter patency prior to use".The ifu also states, "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 a leaking extension line was confirmed through complaint investigation.Visual analysis revealed that the medial extension line contained a hole adjacent to the juncture hub.Functional testing confirmed that fluid leaks from this hole when flushing the medial line.The appearance of the damage is consistent with damage resulting from contact with a sharp instrument (i.E.Scissors, scalpel, etc.).Despite the damage, the catheter met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that damage to the product was discovered when unpacking the central venous catheter.A hole was found in the extension line (cs-15703-e; affected batch number: 71f22m1612) during insertion, and one extension line (de-15853-kwen; affected batch number: 71f24h1309) was found to be slit during preparation.A third catheter was used to resolve the issue.The patient had no harm or injury.The associated emdr report numbers are 3006425876-2025-00155 and 3006425876-2025-00156.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 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: 21374958
• Report Number: 3006425876-2025-00156
• Device Sequence Number: 3848868
• Product Code: DQY
• UDI-Device Identifier: 40801902127714
• UDI-Public: (01)40801902127714(11)221219(17)271130(10)71F22M1612(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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: IPN918515
• Device Catalogue Number: CS-15703-E
• Device Lot Number: 71F22M1612
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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