MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-L 16 GA X 19-1/2 IN (50 CM); CATHETER INTRAVASCULAR THERAPE

Catalog Number	PS-01652
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "the catheter was removed due to a suspected infection." the customer stated they suspect a relationship between the catheter and the infection.Antibiotic treatment was provided.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00792.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one video for analysis.The video shows a used catheter with evidence of ruptures at three locations in the catheter body.Additional information from the customer suggests that the catheter was functional within the patient for ten (10) days prior to the reported rupture and detection of infection.In addition, they confirmed the catheter was not used as a contrast medium.Clinical and medical affairs (cma) was consulted as a part of this investigation.They stated, "no acute symptoms such as fever, hemodynamic instability, or elevated white blood cell count were reported.Clinically, there appears to be a temporal relationship between the use of the catheter and the suspected infection, but there is insufficient evidence to confirm a definite catheter-related bloodstream infection.The intervention was precautionary and successfully resolved the issue without further complications.From a medical standpoint, i would consider this a non-serious event, with the infection suspected but unconfirmed as being related to the device." additionally, ten years of complaint history for finished good ps-01652 were reviewed and there were no confirmed reports of catheter-related infection.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, "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." the contraindication label on the product lidstock states "contraindicati ons: the picc is contraindicated wherever there is presence of device related infections or presence of thrombosis in the intended insertion vessel or catheter pathway.Clinical assessment of the patient must be completed to ensure no contraindications exist." additionally, the catheter in (b)(4) is not a pressure-injectable catheter.The complaint of catheter related infection could not be confirmed based on the information provided and consultation with clinical and medical affairs (cma).Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the catheter was removed due to a suspected infection." the customer stated they suspect a relationship between the catheter and the infection.Antibiotic treatment was provided.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00928 and 9680794-2025-00792.

• Brand Name: ARROW PICC SET: 2-L 16 GA X 19-1/2 IN (50 CM)
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 23554261
• Report Number: 9680794-2025-00928
• Device Sequence Number: 10122939
• Product Code: LJS
• UDI-Device Identifier: 00801902095824
• UDI-Public: (01)00801902095824(11)241202(17)260331(10)14F24K0091(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): 10/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: PS-01652
• Device Lot Number: 14F24K0091
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2024
• 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