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 Obstruction of Flow (2423)

Patient Problems Extravasation (1842); Thrombosis/Thrombus (4440)

Event Date 05/11/2023

Event Type  Injury  

Event Description

Medwatch form received reports: "right internal jugular (rij) quad lumen & rij dl introducer (not specified size) with pa cath placed with us guidance and removed six days later.Right ij double with pa cath and right ij quad lumen extravasation.Epinephrine, vasopressors, isoproterenol, calcium chloride, and insulin running through line.Extravasation protocol followed.Line removed- injury with incision and drainage (i & d) of neck requiring flap 4 weeks after.The rij was thrombosed based on computerized tomography (ct) scan which is the likely cause for extravasation as the lines were in the appropriate location.Line not saved.".

Manufacturer Narrative

Continuation of d11: chloride, and insulin, qn#: (b)(4).

Manufacturer Narrative

Continuation of d11: chloride, and insulinqn#(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.The instructions for use (ifu) provided with this kit warns the user, "clinicians must be aware of complications/undesirable sideeffects associated with this device including, but not limited to.Thrombosis.Warning: do not leave tissue dilator in place as an indwelling catheter.Leaving tissue dilator in place puts patient at risk for possible vessel wall perforation." 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: "right internal jugular (rij) quad lumen & rij dl introducer (not specified size) with pa cath placed with us guidance and removed six days later.Right ij double with pa cath and right ij quad lumen extravasation.Epinephrine, vasopressors, isoproterenol, calcium chloride, and insulin running through line.Extravasation protocol followed.Line removed- injury with incision and drainage (i & d) of neck requiring flap 4 weeks after.The rij was thrombosed based on computerized tomography (ct) scan which is the likely cause for extravasation as the lines were in the appropriate location.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: 17913227
• MDR Text Key: 325403487
• Report Number: 9680794-2023-00780
• 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: 11/02/2023
• 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: EPINEPHRINE, VASOPRESSORS, ISOPROTERENOL, CALCIUM; EPINEPHRINE, VASOPRESSORS, ISOPROTERENOL, CALCIUM
• Patient Outcome(s): Required Intervention