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

Model Number 3600-100

Device Problems Component Missing (2306); Appropriate Term/Code Not Available (3191)

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

Event Date 01/26/2024

Event Type  malfunction  

Event Description

Staff reported an event with the atrium oasis dry suction water seal chest drain.They noted, "when opened to prepare for chest tube insertion, noted that there was no sterile cover for the end of the tubing that connects the actual chest tube to the atrium kit.Unsure if this was still sterile, a different chest tube atrium kit was opened and utilized.Upon inspection of the kit the staff could not find the cover that should have been there.There was a cover on the other atrium kit utilized".

Manufacturer Narrative

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

Manufacturer Narrative

Correction: h6 - medical device - problem code.Additional information: d9 & h6.Investigation summary: this complaint reports that when the oasis drain (p/n 3600-100, l/n 471799) was opened, it did not have a "sterile cover for the end of the tubing that connects the actual chest tub to the atrium kit." this is referring to the cap that covers the barbed connector at the end of the patient tube of many oasis drains.Prior to 10/29/2021, the patient tube set used in the 3600-100 drain was p/n 009445 which included a yellow cap covering the connector.As part of the cost of goods sold (cogs) reduction project, on (b)(6) 2019 the patient tube cap was removed all oasis drain models and drains were manufactured without a cap on the patient tube until (b)(6) 2021, when p/n 009445 was replaced with p/n 011445 which included a white cap over the barbed connector on the end of the patient tube.An increase in customer complaints following the cogs project related to removal of the caps led to capa00343 (which was transferred to trackwise as capa 587545).Patient tube caps were added back onto oasis drains on (b)(6) 2021.The drain in this complaint was manufactured on 6/09/2021, within the time period that a patient tube cap was not included with 3600-100 drains.A dhr review was completed for lot 471799 and no anomalies were identified.An ncr query for lot 471799 was completed and none were identified.The patient tube assembly specification used in lot 471799 was reviewed and it did not include a patient tube cap in the build as per the bom, indicating the absence of a cap is not a device nonconformance.The ifu provides adequate instructions for use of the device.It instructs the user not to use a device if it is damaged.Current complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A recent complaint history review was completed which found one similar complaint of a patient tube cap missing from a device which was not meant to include one.A recurring lot number report was completed for lot 471799 which did not identify any other complaints involving this lot.A review of crs/capas found only the capa mentioned above associated with an increase of complaints following the design change to remove the caps.This complaint is confirmed because it is a known issue and the absence of a patient tube cap on this device is expected and intended of a device manufactured at that time.A device nonconformance cannot be confirmed, as the absence of a patient tube cap matches the patient tube specification from lot 471799.The root cause of this complaint is user preference issue.It is important to note that as per the design change assessment associated with the cap removal, the change did not present risk to patients.Pts cap is not part of the sbs (sterile barrier system), but it contributed to the usability of the device during setup.A cross functional team evaluating the customer feedback concluded that the best strategy would be to reintroduce the cap and revise the user requirements to consider usability outside of the operating room.As part of this plan the user requirements and product requirements were revised to add a requirement for a cap to be used on the patient tube set (pts).As the issue of missing caps resulting in complaints was previously escalated to capa00343 (tw capa 587545), under which the pts caps were added back to the pts tube set assemblies, no further escalation of the complaint is required.Based on the date of reintroduction of the caps, it is expected that all drains manufactured without the cap will expire in q3 2024.

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: 18692420
• MDR Text Key: 335214092
• Report Number: 3011175548-2024-00061
• Device Sequence Number: 1
• Product Code: KDQ
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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: 471799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1