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 Extravasation (1842)

Event Date 01/02/2023

Event Type  malfunction  

Event Description

Medwatch form received reports: "left internal jugular (lij) 9 fr introducer (double lumen (dl)) with pulmonary artery catheter (pa) to introducer placed ultrasound (us) guided and then removed six days later.Extravasated and left neck ecchymosis, black color.Extravasation protocol had been done.Line removed-plastic surgery following patient.Line not saved ".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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

Medwatch form received reports: "left internal jugular (lij) 9 fr introducer (double lumen (dl)) with pulmonary artery catheter (pa) to introducer placed ultrasound (us) guided and then removed six days later.Extravasated and left neck ecchymosis, black color.Extravasation protocol had been done.Line removed-plastic surgery following patient.Line not saved ".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17912902
• MDR Text Key: 325399678
• Report Number: 9680794-2023-00778
• 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: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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 Catalogue Number: ASK-21242-MMC1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/03/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Required Intervention