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	Air/Gas in Device (4062)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch form received reports: "rij introducer double lumen (size not specified) pa to introducer in operating room (or) via us guidance and removed 5 days later.Central line brown port pulling back air and alerting ecmo of venous bubbles.Line was in use with lactated ringers' solution (lr) and insulin running with no prior issues.Line not saved.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(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, "do not suture directly to the outside diameter of access device to minimize the risk of cutting or damaging device or impeding device flow".A device history record review was performed based on a potential lot from sales history, and no relevant findings were identified.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 introducer double lumen (size not specified) pa to introducer in operating room (or) via us guidance and removed 5 days later.Central line brown port pulling back air and alerting ecmo of venous bubbles.Line was in use with lactated ringers' solution (lr) and insulin running with no prior issues.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: 17914200
• Report Number: 9680794-2023-00784
• Device Sequence Number: 7405632
• 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
• 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: LACTATED RINGERS' SOLUTION (LR) AND INSULIN.; LACTATED RINGERS' SOLUTION (LR) AND INSULIN.
• Patient Sex: Unknown