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

Model Number 3600-100

Device Problem Melted (1385)

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When one of the nurses was opening up the oasis 3600-100 to set up to be used on a patient, the drain appeared to be defective as almost if the plastic was melted.Unknown if the outside of the package or box was damaged.Device was not used on a patient.

Event Description

N/a.

Manufacturer Narrative

This complaint reports that a drain was opened and was found to be damaged.The customer described the drain as looking "melted." several parts on the top of the drain are bent and deformed.The customer reported that there was no damage to the pouch and they did not mention any damage to the shipping box.They stated that their drains are stored in a temperature controlled room.The damage to the drain was identified before use, and so it never came into contact with a patient.The device was returned for evaluation.As evident by the white markings on the suction nozzle, caused by polymer crystallization from the plastic being stretched and bent, it does not appear as if heat was the cause of the deformation.Plastic bending due to high temperature does not typically get discolored in this way.Rather, the drain appears as if it were crushed from the top because all of the bends go downward and toward the back of the drain.It appears as if pressure was applied to all the bent parts simultaneously and from the same direction.The damage to the drain is easily noticeable and is extremely unlikely to have passed visual inspection during manufacturing.The lack of any damage to the pouch indicates that the drain was most likely not in the pouch when the damage occurred.If the damage to the drain occurred while it was in its shipping box, both the box and the pouch would have been badly damaged as well, and neither were reported as being so.The force that cause the damage was too powerful and applied too uniformly across the top of the drain to be a drop.It is possible that this could be caused if something heavy like a hospital bed were lowered down on top of it.The lot number of the device was not provided so a dhr review for the specific device lot could not be completed.The dhrs of the 3600-100 drains received shortly before the complaint were reviewed and no anomalies in manufacturing were identified.The investigation details do not indicate that manufacturing, materials, equipment, or design are related to this complaint.The ifu provides adequate instructions for use of the device.The user did not use the damaged device, as instructed by the ifu.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found no similar complaints.A recurring lot number search was performed for five lots of product shipped to the user facility shortly before the complaint, no other complaints were identified for these 5 lots.A review of crs/capas found none related to this complaint.A review of ncrs found none related to this complaint.This complaint is confirmed and a device nonconformance was also confirmed, however it cannot be determined when the nonconformance occurred.An opportunity for the damage to occur during manufacturing was not identified.It most likely occurred during shipping or while in use by the customer.An exact cause could not be identified.The root-cause of this complaint is impossible to define.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 1.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending concluded that the actual occurrence level did not exceed the anticipated occurrence level.No similar complaints were identified.No related crs or capas were identified.No related ncrs were identified.No evidence was identified to suggest that this complaint is related to design, manufacturing or instructions for use.This is an isolated incident which most likely did not occur during manufacturing.

• 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: 17926491
• MDR Text Key: 325836786
• Report Number: 3011175548-2023-00192
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1