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

Catalog Number	CV-25703-E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "patient with difficult venous access for whom a central venous catheter (cvc) placement was indicated.Upon unpacking the device, no apparent damage was observed.During right subclavian vein puncture by the intensivist, needle fracture occurred.A new cvc was requested, with successful placement via left jugular access using sterile technique and no immediate complications processes and inventory management complications." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "referred to another clinic".
Additional Manufacturer Narrative
(b)(4).The actual sample was not returned; however, the customer provided one photo for analysis.The complaint of a broken needle cannula was able to be confirmed by the photo.The image shows an introducer needle with a major kink in its needle cannula.Signs of use were observed.A complete visual inspection could not be performed as no sample was returned for analysis.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, "precaution: do not attempt to remove needles that have been placed into sharps away ii locking disposal cup.These needles are secured in place.Damage may occur to needles if they are forced out of disposal cup." it also states, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished , radiographic visualization should be obtained and further consultation requested." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "patient with difficult venous access for whom a central venous catheter (cvc) placement was indicated.Upon unpacking the device, no apparent damage was observed.During right subclavian vein puncture by the intensivist, needle fracture occurred.A new cvc was requested, with successful placement via left jugular access using sterile technique and no immediate complications processes and inventory management complications." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "referred to another clinic".

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 22457118
• Report Number: 3006425876-2025-00616
• Device Sequence Number: 15526644
• Product Code: FOZ
• UDI-Device Identifier: 10801902029390
• UDI-Public: (01)10801902029390(11)231023(17)250920(10)71F23K0846(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K900263
• 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): 06/16/2025

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 Expiration Date: 09/20/2025
• Device Catalogue Number: CV-25703-E
• Device Lot Number: 71F23K0846
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2023
• 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