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 Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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).

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of a ruptured catheter body was confirmed by the photo.Visual analysis confirmed that the catheter body was ruptured adjacent to the juncture hub.The tear appears uniform and in the direction of the extrusion.The catheter body also appears to be bulging at the location of the tear.This is damage consistent with over-pressurizing; however, a full visual analysis could not be performed as the sample was not returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "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 ifu provided also states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".The customer report of a ruptured catheter was confirmed by visual inspection of the customer supplied photo.The image shows a rupture on the catheter body adjacent to the juncture hub.The catheter body also appears to bulge at this location, which is damage consistent with over-pressurizing during use; however, a full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.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 Description

It was reported that: when the patient 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 patient's current condition is reported as being fine.

• 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: marling heaton ; 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,Followup
• Report Date: 03/04/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: 33F23C0666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/30/2024
• 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.; NOT REPORTED.