MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	ES-04301
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "on (b)(6) 2024, in the second day after insertion, the nurse found the extension line crack.The nurse described the patient as not pulling at all." the operator changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one, single-lumen cvc for analysis.Signs of use were observed on the returned catheter.Visual and microscopic analysis revealed the distal extension line was separated from the luer hub.A section of the extrusion was still molded within the luer hub.The extension line appeared rough and jagged at the point of separation.This damage is consistent with a manufacturing molding defect.The outer diameter of the distal extension line measured 2.19mm, which is within the specification limits of 2.13-2.21mm per the extension line extrusion product drawing.The inner diameter of the distal extension line measured 1.4224mm, which is within the specification limits of 1.42-1.50 mm per the extension line extrusion product drawing.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) provided with this kit informs 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 and microscopic analysis revealed the distal extension line was separated from the luer hub.A portion of the extension line was still molded within the separated luer hub, which is consistent with previous manufacturing molding complaints.A capa has previously been initiated due to an increasing trend of cvc extension line leaks and separations.The capa implementation date (nov 2024) was after the manufacturing of the relevant extension lines (sep 2021).Therefore, based on the appearance of the damage and the capa investigation, manufacturing caused or contributed to this event.Teleflex will continue to monitor and trend complaints of this nature.
Event or Problem Description
It was reported "on (b)(6) 2024, in the second day after insertion, the nurse found the extension line crack.The nurse described the patient as not pulling at all." the operator changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 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: 20797640
• Report Number: 3006425876-2024-01152
• Device Sequence Number: 7980610
• Product Code: DQY
• UDI-Device Identifier: 10801902122756
• UDI-Public: (01)10801902122756(11)211104(17)261031(10)71F21L0047(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: ES-04301
• Device Lot Number: 71F21L0047
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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