MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8IN (50 CM; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-05052-HP
Medical Device Problem Codes	Obstruction of Flow (2423); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the head performs the puncture and inserts the guide, but obstruction is present despite raising the arm and removing the tourniquet.The guide is removed and found to be bent, therefore, insertion is performed in the antecubital area of the msd, the puncture is successful, an accessory guide is inserted, and when the guide is returned, no outlet is obtained through the picc lumen, so the picc is returned and the intensive care physician is notified for cvc." 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).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of a kinked guidewire was able to be confirmed by the photos.One photo shows the guidewire in a clinical setting with multiple kinks and bends in the body.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, "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 that "the head performs the puncture and inserts the guide, but obstruction is present despite raising the arm and removing the tourniquet.The guide is removed and found to be bent, therefore, insertion is performed in the antecubital area of the msd, the puncture is successful, an accessory guide is inserted, and when the guide is returned, no outlet is obtained through the picc lumen, so the picc is returned and the intensive care physician is notified for cvc." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00936 and 9680794-2025-00930.

• Brand Name: ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8IN (50 CM
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23555011
• Report Number: 9680794-2025-00930
• Device Sequence Number: 10053060
• Product Code: LJS
• UDI-Device Identifier: 10801902095388
• UDI-Public: (01)10801902095388(11)250226(17)270131(10)14F25A0270(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• 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): 10/21/2025

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
• Device Catalogue Number: PR-05052-HP
• Device Lot Number: 14F25A0270
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2025
• 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