MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX50CM W/80CM HYDRO NIT SWG; CATHETER INTRAVASCULAR THERAPE

Catalog Number PR-35052-HPHNM

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

When the pt went for ct, staff noted that the contrast was not injecting, leakage noted from picc line.The picc line was removed when back in icu and the lumen was noted to be ruptured.The device was not replaced, issue was resolved by inserting a cvc.Patient complications: the patient did deteriorate due to not being able to receive vasopressor support that was previously running.The patients current condition is reported as being fine.

Manufacturer Narrative

(b)(4).

• Brand Name: ARROW PI PICC 2L 5FRX50CM W/80CM HYDRO NIT SWG
• Type of Device: 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18995111
• MDR Text Key: 338875151
• Report Number: 9680794-2024-00290
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801902101099
• UDI-Public: 00801902101099
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: 33F23C0666
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED