MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRY SUCTION CHEST TUBE; APPARATUS, AUTOTRANSFUSION

Model Number 3600

Device Problems Connection Problem (2900); Material Deformation (2976)

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

Event Date 07/14/2022

Event Type  malfunction  

Event Description

Soft plastic squeeze syringe filled with sterile water provided to inject the sterile water into the atrium has a soft plastic tip that you insert into the atrium.Upon attempting to insert the tip of the soft syringe, the tip would collapse and not be able to be inserted.Fda safety report id# (b)(4).

• Brand Name: OASIS DRY SUCTION CHEST TUBE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• MDR Report Key: 15054880
• MDR Text Key: 296222152
• Report Number: MW5110940
• Device Sequence Number: 1
• Product Code: CAC
• 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: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600
• Device Lot Number: AE 198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 11 DA
• Patient Sex: Female
• Patient Weight: 490 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White