MAUDE Adverse Event Report: SUNMED SUNMED; 90 DEGREE NO PORT CONN 4MM S/S

Model Number 3-3120-40

Device Problems Component Incompatible (1108); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

Reportable as interrupt the ventilation while linking air.Potential of loss of volume due to air leak.

Event Description

Items are not the proper size and leaking air.

Event Description

Items are not the proper size and leaking air.

Manufacturer Narrative

Reportable as interrupt the ventilation while linking air.Potential of loss of volume due to air leak.Summary: product not returned, no product available in inventory for investigation, and product is being discontinued.Ra: rma-(b)(4) risk id (b)(4) identifies "o2 leak between tubing and tubing that is joined by a connector" with risk mitigation as listed: "rc25: ifu states, 'check for leaks at connections and for proper placement prior to use.' ".

• Brand Name: SUNMED
• Type of Device: 90 DEGREE NO PORT CONN 4MM S/S
• Manufacturer (Section D): SUNMED; 2710 northridge dr suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 15220460
• MDR Text Key: 305346625
• Report Number: 1314417-2022-00019
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3-3120-40
• Device Catalogue Number: 3-3120-40
• Device Lot Number: 20-0780
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other