MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number CDC-45703-XP1A

Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Event Description

The patient came to ct accompanied by a transporter, rt, and the primary rn.The patient had a power injectable triple lumen central venous catheter (cvc) in the right neck.The white lumen of the cvc was available for use and the preferred line for contrast administration.The line was verified to be power injectable to 5 ml/s per the manufacturer by observing the marking on the hub of the catheter.Brisk blood return was confirmed, and the catheter flushed without difficulty.The injection of contrast was carried out by the ct technologist at a rate of 4 ml/s with no difficulties.The patient status remained unchanged after contrast injection.After injection and upon assessment of the catheter, it was noted that the white lumen appeared expanded, flimsy, and warped.Blood return was confirmed, and the catheter flushed without difficulty.A hemostat was placed over the distal end of the lumen to protect against blood backflow or air infiltration.No harm to the patient.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 15892999
• MDR Text Key: 304594195
• Report Number: 15892999
• 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: 11/21/2022,10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 13F22F0676
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10950 DA
• Patient Sex: Male
• Patient Weight: 103 KG