MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW THORACENTESIS KIT; CATHETER AND TIP SUCTION

Catalog Number	AK-01000
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "introducer catheter folded back onto itself preventing advancement.Upon removal the catheter was found to be intact but folded.There was patient involvement, no harm, no medical intervention, patient is doing well.".
Additional Manufacturer Narrative
(b)(4).The reported issue 'catheter folded' could not be confirmed upon investigation of the returned sample.The customer returned one unit of the catheter.No damage or abnormalities were observed on the unit.The needle was not returned to confirm any defects present.Additional information indicated that the patient had no harm.No medical intervention was carried out.Patient condition was fine.A dhr review was completed for and no issues or non-conformities were noted.It is unknown if the needle could have caused any folding issues during use along with catheter.Based on limited information, the most likely root cause of the issue is undeterminable.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "introducer catheter folded back onto itself preventing advancement.Upon removal the catheter was found to be intact but folded.There was patient involvement, no harm, no medical intervention, patient is doing well.".

• Brand Name: ARROW THORACENTESIS KIT
• Common Device Name: CATHETER AND TIP SUCTION
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24442671
• Report Number: 9680794-2026-00151
• Device Sequence Number: 10212452
• Product Code: JOL
• UDI-Device Identifier: 30801902120121
• UDI-Public: (01)30801902120121(11)251110(17)280331(10)33F25H0192(21)
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K870572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: AK-01000
• Device Lot Number: 33F25H0192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2025
• 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