MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN/PSI KIT 9 FR X 11.5 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number ASK-21242-MMC1

Device Problem Fluid/Blood Leak (1250)

Patient Problem Burning Sensation (2146)

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported "mac catheter extravasation.The patient felt burning from potassium." the catheter was removed and a new catheter was placed.The placement was successful.The patient's current condition is reported as "fine".

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, "precaution: do not suture directly to the outside diameter of access device to minimize the risk of cutting or damaging device or impeding device flow." 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 "mac catheter extravasation.The patient felt burning from potassium." the catheter was removed and a new catheter was placed.The placement was successful.The patient's current condition is reported as "fine".

• Brand Name: ARROW MULTILUMEN/PSI KIT 9 FR X 11.5 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18558387
• MDR Text Key: 333455135
• Report Number: 9680794-2024-00070
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902112054
• UDI-Public: 10801902112054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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: ASK-21242-MMC1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/26/2024
• 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.