MAUDE Adverse Event Report: BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD. NOVALINE BL 11; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Lot Number 2101010231

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2022

Event Type  malfunction  

Event Description

Air in arterial line in blood line novaline bl11, lot #2101010231.Blood flow rate (bfr) 295, arterial pressure-220 (normal is below -250).Taped the connection from needle to blood line as advised by (b)(6) 2023, but air is still there.Air goes away temporarily after tapping line but comes back same place after minutes.Baxter called and placed product complaint, ref #3771749, spoke with a (b)(4).Packed the blood line with (b)(6) 2022 blood line samples (x2) together, storeroom to ship back to baxter.Fda safety report id# (b)(4).

• Brand Name: NOVALINE BL 11
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.
• MDR Report Key: 14946335
• MDR Text Key: 295500794
• Report Number: MW5110714
• 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: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2101010231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male