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 Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 06/04/2023

Event Type  malfunction  

Event 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.".

Manufacturer Narrative

(b)(4).

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 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
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17914200
• MDR Text Key: 325412453
• Report Number: 9680794-2023-00784
• 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?: 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
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/01/2023
• 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: LACTATED RINGERS' SOLUTION (LR) AND INSULIN.; LACTATED RINGERS' SOLUTION (LR) AND INSULIN.