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); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch form received reports: "rij introducer w/ pac through it placed via us with tee, removed 2 days later.Sat patient up in the cardiac chair mode and noted the rij cordis site was leaking and the chlorhexidine gluconate (chg) of the transparent dressing was soaked.Epinephrine and isuprel were infusing.Bedside lung ultrasound in emergency (blue) ultrasound done and noted a large occlusive clot.Extravasation protocol followed and injections done.Cns has line.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Medwatch form received reports: "rij introducer w/ pac through it placed via us with tee, removed 2 days later.Sat patient up in the cardiac chair mode and noted the rij cordis site was leaking and the chlorhexidine gluconate (chg) of the transparent dressing was soaked.Epinephrine and isuprel were infusing.Bedside lung ultrasound in emergency (blue) ultrasound done and noted a large occlusive clot.Extravasation protocol followed and injections done.Cns has line.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "some disinfectants used at the access device insertion site contain solvents, which can attack the catheter material.Assure insertion site is dry before dressing".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: date of incident changed to (b)(6) 2023 after receipt of additional information.Codes added for occlusion and extravasation.

• 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: 17913327
• Report Number: 9680794-2023-00782
• Device Sequence Number: 17805706
• 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?: No
• 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: 10/31/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/01/2023
• 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: EPINEPHRINE AND ISUPREL.; EPINEPHRINE AND ISUPREL.
• Patient Sex: Unknown