MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRY SUCTION WATER SEAL CHEST DRAIN

Model Number 3600-100

Device Problems Air Leak (1008); Crack (1135); Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 02/15/2016

Event Type  Injury  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated that no cracks were noticed when the drain was removed from the sterile packaging.However, when the drainage system was connected to the patient, the system did not work properly - suction of the air and cracking was noticed.

Manufacturer Narrative

Engineering analysis: unit was not available to be returned for evaluation.A companion sample was returned and evaluated.The companion sample upon inspection showed that the drain had a large crack in the device most likely from shipping/handling damage.Drains are 100% leak tested with an automated system and then inspected by each operator as it progress down the production line.The lot number was not provided for the drain therefore a device history record review was not performed.The instructions for use (ifu) states in the precaution section "do not use if package is damaged".Summary/conclusion: without having the actual drain the damage cannot be confirmed, but from the reported incident description it appears that the root cause is shipping damage incurred during transport and/or handling.

• Brand Name: OASIS DRY SUCTION WATER SEAL CHEST DRAIN
• Type of Device: OASIS DRY SUCTION WATER SEAL CHEST DRAIN
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 5508478
• MDR Text Key: 40631558
• Report Number: 1219977-2016-00044
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 03/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 90