MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number IPN918726

Device Problem Obstruction of Flow (2423)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

It was reported "several patients were involved in similar incidents where non-administration of norepinephrine, linked to obstruction of the catheter's side eyes by clot formation, led to significant variations in blood pressure in the patients concerned.Additional information reports, "to solve the problem, we first swapped the noradrenaline on the distal line, then changed the catheter in a second step.The 2nd kit was inserted with no problem".The patient's current condition is reported as fine with the "patient out of the department".Associated mdr number 3006425876-2024-00170.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.Minimize catheter manipulation throughout procedure to maintain proper catheter tip position." a device history record review was performed based on a potential lot from sales history, and no relevant findings were identified.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.

Event Description

It was reported "several patients were involved in similar incidents where non-administration of norepinephrine, linked to obstruction of the catheter's side eyes by clot formation, led to significant variations in blood pressure in the patients concerned.Additional information reports, "to solve the problem, we first swapped the noradrenaline on the distal line, then changed the catheter in a second step.The 2nd kit was inserted with no problem".The patient's current condition is reported as fine with the "patient out of the department".Associated mdr number 3006425876-2024-00170.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18767792
• MDR Text Key: 336626390
• Report Number: 3006425876-2024-00169
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN918726
• Device Catalogue Number: CV-12854
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NONE REPORTED.; NONE REPORTED.