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 Codes	Extravasation (1842); Scar Tissue (2060)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Medwatch form received reports: "rij 9 fr dl introducer placed via us guidance and removed 2.5 weeks later.Extravasation noted at right ij central venous access catheter site while performing site care; actual date of extravasation not clear as there are multiple episodes of leaking catheter/site with dressing changes performed for several days prior; patient received vasopressors and antibiotics at various intervals.Consult of site revealed no underlying necrotizing soft tissue injury but will need debridement at some time in future.Non obstructive clot of rij seen on ct scan of neck 2 days post removal.Site being monitored.No line saved.".
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, "clinicians must be aware of complications/undesirable sideeffects associated with this device inclu ding, but not limited to.Extravasation.Warning: to reduce the risk of possible vessel wall perforation, do not leave tissue dilator in place as an indwelling catheter." 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.Corrected data: event date changed to 07/14/2023 after receipt of additional information.Codes added for scar and another device needed.Additional information informed us that the patient was deceased.Time interval between the complaint issue and death was 12 days.Cause of death was respiratory failure.It was stated that the death was not caused by the incident.
Event or Problem Description
Medwatch form received reports: "rij 9 fr dl introducer placed via us guidance and removed 2.5 weeks later.Extravasation noted at right ij central venous access catheter site while performing site care; actual date of extravasation not clear as there are multiple episodes of leaking catheter/site with dressing changes performed for several days prior; patient received vasopressors and antibiotics at various intervals.Consult of site revealed no underlying necrotizing soft tissue injury but will need debridement at some time in future.Non obstructive clot of rij seen on ct scan of neck 2 days post removal.Site being monitored.No line saved.".

• 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: 17914110
• Report Number: 9680794-2023-00783
• Device Sequence Number: 20496499
• 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: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/03/2023
• 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: VASOPRESSORS AND ANTIBIOTICS; VASOPRESSORS AND ANTIBIOTICS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown