MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAIN OCEAN SINGLE; BOTTLE, COLLECTION, VACUUM

Model Number	2002-300
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Report received stated that during an inspection of an oasis drain in the warehouse it was observed that the tyvek pouch on the drain had a hole.
Additional Manufacturer Narrative
Corrected data.Additional information: investigation: the customer reported that they received an ocean drain with a small tear in the tyvek pouch.This complaint has been confirmed with photographs provided by the customer.No evidence could be identified that this damage occurred during manufacturing and no trends were identified in complaint trending or in the complaint history review.No conclusive cause of this damage could be identified, so the root-cause is "impossible to define." a trend review was completed which identified one excursion beyond 3 standard deviations in april 2022, however per sp009220, complaint metrics, a capa request is not required for a singular event.A complaint history review was completed which did not identify any other complaints that could be leveraged to aid in this investigation.No cars/capas/ncrs/scars were identified that were related to this reported defect.A dhr review was completed which did not find any nonconformances during the manufacturing process of this lot.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.No field actions or corrective actions have been identified for this reported defect.Based on the findings of this investigation, no escalation is needed to corrective actions.H3 other text: not available for return.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The product was returned for evaluation and the tear in the tyvek pouch was observed.The tear is small and near the edge of the pouch.There is some crinkling under the tear and appears to have been caused by something rubbing over or pushing on the surface of the pouch and not by a sharp instrument.Based on the evaluation of the returned product, the cause of the reported defect could not be determined.

• Brand Name: DRAIN OCEAN SINGLE
• Common Device Name: 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: 14089783
• Report Number: 3011175548-2022-00122
• Device Sequence Number: 4895070
• Product Code: KDQ
• UDI-Device Identifier: 00650862100105
• UDI-Public: 00650862100105
• Combination Product (Y/N): N
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2024
• Device Model Number: 2002-300
• Device Catalogue Number: 2002-300
• Device Lot Number: 476008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 07/28/2022; 09/19/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 08/01/2022; 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT APPLICABLE.
• Patient Sex: Unknown