MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM PICC 2L 5.5FRX55CM 130CM HYDR NIT SWG; INTRODUCER, CATHETER

Catalog Number	PR-45552-HPHNL
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the product was used for a picc procedure at (b)(6) hospital on (b)(6).After inserting the device through the sheath and attempting to advance it, resistance was felt within the vessel (basilic vein), making it difficult to progress the catheter.The catheter was removed, and the procedure was completed using another picc product." 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 customer returned a pi picc kit for analysis including a peel-away sheath over a 2-lumen catheter , guillotine, scalpel, guidewire inside the advancer, dilator, and needle.Dried medication was observed inside the extension lines.Signs of use in the form of biological material were observed on the catheter body.The catheter body was returned with the distal tip intentionally trimmed.The severed portion of the catheter was not returned.No other defects or anomalies were observed.The catheter body length measured 15 1/8" which indicates 7 5/8" - 7 7/8" of the catheter body was severed per the catheter product drawing.The catheter body outer diameter measured.074", which is within the specification limits of.069" -.074" per the catheter extrusion product drawing.The inner diameter at the distal tip of the peel-away sheath measured.077" which is within the specification limits of.077" -.078" per peel-away sheath product drawing.The outer diameter of the peel-away sheath measured.099" which is within the specification limits of.094" -.104" per peel-away sheath product drawing.The returned catheter was removed from the returned peel-away sheath and reinserted.The catheter was able to advance through the sheath with minor resistance in areas of dried biological material.Once the dried biological material had been cleared from the components, the device functioned as expected.Performed per ifu statement, "insert catheter through peel-away sheath to final indwelling position.Retract and/or gently flush while advancing catheter if resistance is met." a device history record review was performed, and there were two findings.A non-conformance was initiated for (b)(6) in regard to "low concentration of chx itm3" and a non-conformance was initiated for (b)(6) in regard to "missing component".Review of these findings concluded that they are not relevant to the reported issue as the reported issue is mechanical in nature and the findings do not indicate mechanical issues with the relevant components.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." the report of difficulty advancing a catheter into a patient was not confirmed through analysis of the returned sample.The catheter and sheath met all relevant functional and dimensional requirements.A device history review record did not reveal any findings relevant to the reported defect.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the product was used for a picc procedure at (b)(6) hospital on (b)(6).After inserting the device through the sheath and attempting to advance it, resistance was felt within the vessel (basilic vein), making it difficult to progress the catheter.The catheter was removed, and the procedure was completed using another picc product." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported that "the product was used for a picc procedure at (b)(6).After inserting the device through the sheath and attempting to advance it, resistance was felt within the vessel (basilic vein), making it difficult to progress the catheter.The catheter was removed, and the procedure was completed using another picc product." 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).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and two potential findings were identified.As no sample was returned for investigation, it could not be determined if the findings were relevant to the reported event.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: ARROW AM PICC 2L 5.5FRX55CM 130CM HYDR NIT SWG
• Common Device Name: INTRODUCER, CATHETER
• 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: 23864586
• Report Number: 9680794-2025-01054
• Device Sequence Number: 18466440
• Product Code: DYB
• UDI-Device Identifier: 00801902095770
• UDI-Public: (01)00801902095770(11)250411(17)261031(10)33F25C0068(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K780532
• 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,Followup
• Report Date (Section B): 11/27/2025

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-45552-HPHNL
• Device Lot Number: 33F25C0068
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 02/10/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/21/2026; 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown