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	Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	07/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch form received reports: "rij central venous catheter (cvc) (triple lumen) placed us guided and then removed 5 days later.Patient had right ij cvc central line.Oozy and needing several dressing changes.Neck site painful, irritated, macerated.Patient received multiple doses of pain meds, site redressed, and ice applied.Site pink/ moist irritated no evidence of underlying tissue injury.Line not saved.".
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 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".Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
Medwatch form received reports: "rij central venous catheter (cvc) (triple lumen) placed us guided and then removed 5 days later.Patient had right ij cvc central line.Oozy and needing several dressing changes.Neck site painful, irritated, macerated.Patient received multiple doses of pain meds, site redressed, and ice applied.Site pink/ moist irritated no evidence of underlying tissue injury.Line not 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: 17913307
• Report Number: 9680794-2023-00781
• Device Sequence Number: 17798899
• 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
• Device Lot Number: UNKNOWN
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown