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

Model Number 3600-100

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/29/2023

Event Type  malfunction  

Event Description

Nurse educators were training nurses in the icu on how to inject tpa through the patient tubing of the oasis 3600-100 chest drain.They had noticed it does leak a little at the injection site.They said they had the tubing clamped for over an hour.The nurse educator advised they were using 25g and 21g needle.Pictures attached.No patients were harmed as this was only used for education and was not connected to any patients.

Manufacturer Narrative

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

Manufacturer Narrative

Related mdr's: 3011175548-2023-00096 & 3011175548-2023-00097.This complaint reports that nurse educators experienced leaks in patient tubes of oasis drains (p/n 3600-100) while training nurses how to inject tpa (tissue plasminogen activator) into the tubes to aid in drainage.They stated that they used 25 gauge and 21 gauge needles to administer the injections and pierced the tubes at a 45 degree angle.They stated that the drains were clamped shut when the injection was performed and remained that way for over an hour.In that time they noticed a small amount of leaking at the injection sites when pressure (pressing on the tube) was applied.These drains never came into contact with patients.The customer provided pictures of the needles used as well as a picture of one of the patient tubes which does appear to have a small amount of liquid outside of the tube while it is being lightly pinched.The user reported using the drain in a way it is not intended for and also reported that the leak only occurs when pressure is applied to the tube, suggesting the injection site did squeeze back closed and only opens when the tube is manipulated.The drains were returned for evaluation and it was found that one of them allowed a small leak of fluid from the injection site when the tube is significantly manipulated.The amount leaked was in allowance by the product requirement document and does not constitute a device nonconformance.The leak only occurred with one of the three drains could not be replicated a second time.The dhrs of the three lots involved were reviewed and no nonconformities or anomalies in its manufacturing were identified.No steps in the manufacturing process performed by getinge were identified that would affect the elastic properties of patient tubes.The complaint reports that the leak occurred through the puncture holes the user created with needles, so it is not believed that this complaint occurred due to damage sustained during manufacturing.The patient tubes used in these lots passed all incoming inspection criteria.No changes in the part specifications of the finished drain, the patient tube assembly, or the base patient tube were identified which would contribute to this complaint.An ncr query related to the three involved lots was completed and none were identified.The ifu instructs the user not to use the drain if the device or packaging is damaged and gives instructions for how to take a sample from the patient tube (the only recommended reason to puncture the patient tube).Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.One excursion was identified in december 2022 for the failure rate exceeding the 3 standard deviation limit, however this was due to reasons unrelated to this complaint.A complaint history review was completed which found no related complaints.Recurring lot number reports were completed which found no additional complaints against lots 490750, 492076, or 492632.A review of cars/capas found no related cars or capas.A review of scars identified none related to this complaint.A review of ncrs did not find any related to this complaint.The information provided by the user and observed during the device evaluation was adequate to confirm the complaint, however it was not adequate for confirming the device was nonconforming when it left getinge.Because the patient tube was being used in a way that the user preferred and not in a way recommended by the ifu and no device nonconformity was identified, the root-cause of this complaint is user preference issue.

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: 16714435
• MDR Text Key: 313169312
• Report Number: 3011175548-2023-00098
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• 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
• Device Lot Number: 492632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1