MAUDE Adverse Event Report: VYAIRE MEDICAL OY VITAL SIGNS¿ SILICONE TUBE, ADULT, 1.0 M/40 IN, CONNECTORS 22/22 MM, REUSABLE; CONNECTOR, AIRWAY (EXTENSION)

Model Number CIRCUIT REUSABLE (A) SILICONE

Device Problem Connection Problem (2900)

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

Event Date 10/24/2022

Event Type  malfunction  

Manufacturer Narrative

"device evaluated by mfr: the defective sample is not available for return, there is no photo and the lot number is unknown.No root cause has been determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available." the sample is not available for return.

Event Description

It was reported to vyaire medical that the vital signs¿ silicone tube, adult, 1.0 m/40 in, connectors 22/22 mm, reusable does not stay attached to the connector which connects to the fitting of the anesthesia cabinet.The issue happened during patient use, but there was no patient harm.

• Brand Name: VITAL SIGNS¿ SILICONE TUBE, ADULT, 1.0 M/40 IN, CONNECTORS 22/22 MM, REUSABLE
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2 helsinki ete; la-suomen laani, finland fin; helsinki ; FI
• Manufacturer (Section G): SILIKON-TECHNIK SILTEC GMBH & CO. KG; jakob-lang-strasse 12; weiler-simmerberg ; GM
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16043342
• MDR Text Key: 308258409
• Report Number: 3010838917-2022-00034
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CIRCUIT REUSABLE (A) SILICONE
• Device Catalogue Number: M1012209
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1