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
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem 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".
Additional Manufacturer Narrative
(b)(4).
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9680794-2024-00070
• Device Sequence Number: 12659211
• Product Code: FOZ
• UDI-Device Identifier: 10801902112054
• UDI-Public: 10801902112054
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown