MAUDE Adverse Event Report: NOVALINE AK98 TUBING SET FOR HEMODIALYSIS; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number BL 11 SAP CODE 955554

Device Problem Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 11/25/2021

Event Type  malfunction  

Event Description

Micro bubbles found in arterial line of novaline ak98 machine cartridge.Fda safety report id# (b)(4).

• Brand Name: NOVALINE AK98 TUBING SET FOR HEMODIALYSIS
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• MDR Report Key: 12954683
• MDR Text Key: 281979709
• Report Number: MW5105882
• Device Sequence Number: 1
• Product Code: FJK
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Catalogue Number: BL 11 SAP CODE 955554
• Device Lot Number: 2001010714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Race: Asian