MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number IPN925134

Patient Problem Pneumothorax (2012)

Event Date 12/09/2023

Event Type  Injury  

Event Description

The patient arrived from the emergency department with a left femoral triple lumen iv line.The patient was very ill on mechanical ventilator and four vasopressor medications, etc.Doctor and a nurse were at the patient bedside.One x-ray technician (tech) came to the patient room to do a stat portable anterior-posterior (ap) abdominal x-ray.The tech brought the portable to the room by himself, and the rn asked if he needed help.The tech declined help as the patient was of smaller body habitus and weighed approximately 120 lbs.The tech thought he was able to place the image receptor without assistance.The tech placed the image receptor from the patients right.He clipped anatomy and needed to retake the x-ray.The tech pulled the board out of the way on the patients left side, readjusted it, and as the tech was pushing the image receptor back under the patient, he heard a small pop.The tubing that was in the patients left groin had snapped.Top part of the distal port of the central venous catheter (cvc) line.The rn was in the room and heard the pop as well.The reaction time from the pop to the rn clamping the tube in the patients left groin was approximately 5-10 seconds.After the tube was clamped, the tech realized the urgency of what happened and took the image receptor out from underneath the patient to get out of the way.A respiratory therapist was nearby the room, the nurse that clamped the tube called for the doctor right away and another rn that was nearby also came into the room to provide immediate care to patient.Doctor had to place new central line in patient which caused a small pneumothorax in the patient.Patient had to get chest tube placed and additional x-rays done.

• Brand Name: ARROW
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 18685246
• MDR Text Key: 335125386
• Report Number: 18685246
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2023

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: Other
• Device Model Number: IPN925134
• Device Catalogue Number: CDC-45703-XPN1A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male