MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; BOTTLE, COLLECTION, VACUUM

Model Number 3600-100

Device Problem Disconnection (1171)

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

Event Date 09/15/2023

Event Type  malfunction  

Event Description

During transport of the the patient the inline connector was disconnected from the patient tubing.The line was reconnected with no harm to the patient.

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Manufacturer Narrative

Investigation: this complaint reports that the in-line connector of a 3600-100 oasis drain came disconnected from the patient line while the patient was being transported in a hospital bed, leaving the fluid path open to the air.The customer stated that the connections were secure when the patient left their room and when they arrived at the next room.The line was disconnected when the patient returned to their room.It is not known exactly how long the line was disconnected, but it was reconnected within a minute of the disconnect being discovered.They sterilized the two open ends and reconnected the line.They reported that there was no additional patient harm as a result of this incident.The customer reported that the drain had been in place for several days and had collected about 500ml of fluid.As far as they know, the line had not previously been disconnected.The drain was not returned and the lot number was not provided.A dhr review could not be completed.The investigation details do not indicate that there was an issue with manufacturing, materials, equipment, or design.No evidence was provided by the customer to confirm this complaint or confirm a device nonconformance.The details of the complaint suggest that the detachment of the patient line from the in-line connector likely occurred during transportation, which could explain how the required force was applied to the connection to pull it apart.However, there is no way to know specifically how this occurred.No evidence was identified to suggest that manufacturing, materials, equipment, or design contributed to this complaint.The root-cause of this complaint is impossible to define.The ifu provides adequate instructions for use of the device.A complaint history review was completed which found no similar complaints.A recurring lot number report could not be completed because the lot number was not provided.A review of ncrs found none related to this complaint.H3 other text : device not available for return.

Event Description

N/a.

• Brand Name: DRAINS OASIS SINGLE
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 17831496
• MDR Text Key: 324441657
• Report Number: 3011175548-2023-00186
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1