MAUDE Adverse Event Report: ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V. ARROW SINGLE-LUMEN INFUSION CATHETER (SLIC); INTRODUCER, CATHETER

Model Number IPN039999

Device Problem Use of Device Problem (1670)

Patient Problem Perforation of Vessels (2135)

Event Date 03/31/2022

Event Type  Injury  

Event Description

Through several review, an identified trend with single lumen infusion catheter and intraoperative complication - device had perforated junction of the superior vena cava and the innominate vein.This was repaired during the surgery and line was removed.Determined that this device type is no longer used by anesthesia group.Fda safety report id # (b)(4).

• Brand Name: ARROW SINGLE-LUMEN INFUSION CATHETER (SLIC)
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V.; MX
• MDR Report Key: 14676472
• MDR Text Key: 293962845
• Report Number: MW5110264
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10801902148091
• UDI-Public: (01)10801902148091
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN039999
• Device Catalogue Number: SC-14701
• Device Lot Number: 14F19K0503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White