MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS SINGLE CHEST DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 3600-100

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2021

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

Report received stated that an adult chest drain was selected from the shelf and used on an infant.The report also stated that the facility felt there was not a significant difference between the single collection and infant/pediatric kits in regard to the product labeling color.There was no reported issues with the actual drain.

Manufacturer Narrative

Additional information e.1 - event site telephone and email.Corrected information e.1 - occupation and initial reporter.Added uf report (b)(4).

Event Description

N/a.

Manufacturer Narrative

This complaint does not allege any problems with the device itself, but claims that the devices 3612-100 and 3600-100 are difficult to distinguish from each other while in their pouches and requested the following changes be made to the packaging: possible color change showing difference between single collection and infant peds; can the package list the fr sizes of chest tubes that will fit the reservoir; can the coupling/fitting be listed as we noticed the two sizes had different connections.The single collection drain (3600-100) was used on an infant, with no reported adverse effects.The device has not been returned, however a picture of the device alongside an infant/pediatric kit (both in their packaging) was sent.The labeling specifications for 3600-100 and 3612-100 were reviewed and no nonconformities can be identified in the packaging or labeling of either device in the picture.The labeling of both devices contains all information required to identify the device.Specifically, the labeling contains the product code and a description.3600-100 is labeled "single collection" while 3612-100 is labeled "infant pediatric." the lot number of the used device was not provided.In the absence of a confirmed lot number, a dhr review was performed for lot 447051 (the example device in the picture) to identify any nonconformities in the manufacturing of the listed lot number.No nonconformities were identified and no material was scrapped from the label generation step, which includes instructions for identifying defects.This indicates that no nonconforming material was discovered during the generation or inspection of the product labels.Additionally, there were no issues identified at the manufacturing label reconciliation or the qc label verification steps.This lot of devices passed all quality requirements during the manufacturing process.Because the customer did not allege any nonconformities with the device or its packaging and no evidence of nonconformance was found during investigation, this device cannot be confirmed as nonconforming.

Event Description

N/a.

• Brand Name: OASIS SINGLE CHEST DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• 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: 11359060
• MDR Text Key: 241751355
• Report Number: 3011175548-2021-00201
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• 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 Sex: Female