MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS CLEAR PRESSURE INFUSOR; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number VITAL SIGNS® CLEAR PRESSURE INFUSOR

Device Problem Leak/Splash (1354)

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

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the vital signs clear pressure infusor has tubing leaks at stopcock.But unknown which of the two lot numbers (180989 and 180990) has the leak.The issue occurred during patient-use and the customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: VITAL SIGNS CLEAR PRESSURE INFUSOR
• Type of Device: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VINCENT MEDICAL (DONGGUAN) MANUFACTURING CO., LTD; 45-46 shabu industrial zone; qiao long district, tangxia; dongguan, 52373 0; CH 523730
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 10731098
• MDR Text Key: 213203628
• Report Number: 3004050971-2020-00010
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/28/2020

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 Operator: Health Professional
• Device Model Number: VITAL SIGNS® CLEAR PRESSURE INFUSOR
• Device Catalogue Number: IN800020
• Device Lot Number: 180990, 180989
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1