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

Model Number 3600-100

Device Problems Device Contamination with Chemical or Other Material (2944); Appropriate Term/Code Not Available (3191)

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

Event Date 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Report received stated that the customer found a hair in the packaging of an oasis drain.

Event Description

N/a.

Manufacturer Narrative

This complaint claims that a hair was found in the packaging of an oasis single drain after it was opened.Based on the details provided by the customer and the information reviewed during the investigation, it cannot be confirmed that the device was non-conforming to it's specifications.No pictures were sent by the customer to show the device with the hair in the packaging.The packaging had been torn all the way open when it was returned for evaluation and no hair could be found.There is no way to confirm that a hair was present in the sealed product.However, this type of nonconformance has been known to occur and it cannot be ruled out, so the root-cause of this complaint is manufacturing - assembly.The dhr for this lot was reviewed and no nonconformances or anomalies were identified.The ifu instructs the user not to use a device if the device or packaging is defective, and those instructions were followed.The ifu was adequate for this occurrence.Complaint trending was reviewed and identified one excursion in july 2022, for which a car was submitted and is under review.A complaint history review found two other complaints related to hair in the packaging, but neither of them have been confirmed.A review of cars/capas found one related car, which did not result in a capa.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.

• Brand Name: DRAINS OASIS SINGLE
• 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: 14723902
• MDR Text Key: 296142665
• Report Number: 3011175548-2022-00171
• Device Sequence Number: 1
• Product Code: CAC
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2022
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 478348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1