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

Model Number IPN039999

Device Problem Use of Device Problem (1670)

Patient Problem Perforation of Vessels (2135)

Event Date 03/15/2022

Event Type  Injury  

Event Description

After several reviews, it was noted that there was an injury during surgery that was a trend.After opening the chest for surgery, the single lumen infusion catheter was noted to be through the inferior aspect of the innominate vein.The line was removed, and the vein was repaired.Fda safety report id # (b)(4).

• Brand Name: ARROW SINGLE-LUMEN INFUSION CATHETER (SLIC)
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): ARROW NTERNACIONAL DE CHIHUAHUA S.A. DE C.V.; MX
• MDR Report Key: 14676367
• MDR Text Key: 293963797
• Report Number: MW5110262
• Device Sequence Number: 1
• Product Code: KGZ
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White