MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAPE

Catalog Number CDC-45703-XP1A

Device Problem Material Separation (1562)

Patient Problem Air Embolism (1697)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Patient pulled on lumens of the catheter and pulled out the middle lumen.It was reported with the middle lumen pulled out this has left an open hole through the pathway of the catheter into the vasculature causing a possible air embolism which was under investigation at the facility.The patient's condition was reported to be critical with a possibility of death.Additional information was requested from the user facility, but was not available at the time of this report.

Manufacturer Narrative

Qn#(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of an extension line/juncture hub separation was able to be confirmed by the photos.The photos revealed the distal extension line had completely separated from the juncture hub.The distal extension line was not pictured.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." based on the customer description and the returned photos, user error - unintentional patient damage caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Patient pulled on lumens of the catheter and pulled out the middle lumen.It was reported with the middle lumen pulled out this has left an open hole through the pathway of the catheter into the vasculature causing a possible air embolism which was under investigation at the facility.The patient's condition was reported to be critical with a possibility of death.Additional information was requested from the user facility, but was not available at the time of this report.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13118887
• MDR Text Key: 282973150
• Report Number: 1036844-2021-00178
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F21J0129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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.
• Patient Outcome(s): Life Threatening