MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 1L 4FRX55CM W/130CM HYDR NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35541-HPHNL
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "picc has kink pt side near hub." the device was removed and replaced.There was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one, 1-lumen pressure injectable (pi) picc catheter for analysis.Signs of use in the form of biological material were observed on the catheter body.It was noted that the catheter body was trimmed at the 40cm marking.The severed portion was not returned.Visual analysis revealed two kinks observed near the juncture hub.Microscopic examination confirmed the damage.No other defects or anomalies were observed.Two kinks measured 2mm and 6mm from the juncture hub.The catheter body length from the juncture hub to the severed end measured 41.7cm, which indicates that between 14.16cm-15.44 cm of the catheter body was severed and not returned (per catheter product drawing).The catheter body outer diameter measured 0.055", which is within the specification limits of 0.054"-0.057" per the catheter body extrusion product drawing.A lab inventory syringe filled with water was attached to the extension line and flushed.No obvious resistance or blockages were observed.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".A lab inventory guide wire (outer diameter measured 0.0175") was inserted through the distal lumen.Minor resistance was encountered at the location of the kinking.Performed per ifu statement, "if 130 cm guidewire is used, insert soft tip of the guidewire through peel-away sheath to desired depth.Thread catheter over guidewire and advance catheter over guidewire to final indwelling position using image guidance or fluoroscopy." a device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "ensure catheter patency prior to use, including prior to pressure injection.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.Power injector equipment may not prevent over pressurizing an occluded or partially occluded catheter".The ifu also states, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage".The ifu also states, "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 a kinked catheter was confirmed through complaint investigation.Visual analysis revealed two kinks near the juncture hub.Minor resistance was noted at the kinking when passing a lab inventory guide wire through the catheter.Despite the damage, the catheter met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report that the damage was observed during use and the evaluation of the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "picc has kink pt side near hub." the device was removed and replaced.There was no patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW PI PICC 1L 4FRX55CM W/130CM HYDR NIT SWG
• 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: 23244108
• Report Number: 9680794-2025-00816
• Device Sequence Number: 18690957
• Product Code: LJS
• UDI-Device Identifier: 00801902095565
• UDI-Public: (01)00801902095565(11)241106(17)260331(10)33F24K0699(21)
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: PR-35541-HPHNL
• Device Lot Number: 33F24K0699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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