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

Model Number	2002-300
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/25/2021
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 the package was found broken while taking out from the carton box prior to leaving distributor.
Additional Manufacturer Narrative
Additional information: d 10.Product retuned.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Based on the details of the complaint and the photos provided the sterile barrier (the outer pouch) and inner csr wrap had been punctured deeming the product unsterile.On examination of the chest drain it was clear that the outer pouch had been punctured and extended deep enough into the packaging to also puncture the csr blue wrap as well as dent the corner of the drain itself.A review of the packaging process shows that there are no opportunities for such random damage to occur.Once the product is placed within the pouch prior to sealing the pouch and materials are again inspected.As the damage noted appears to have occurred after the product was packaged, the process of packaging does not appear to be a cause of the damage noted during the return investigation.A review of the raw materials, specifically the product pouch and blue csr at the incoming inspection level has not identified any abnormalities or non-conformances.The location of the damage is too far below the location of the sealed pouch to suggest that the sealer equipment had a role in creating the damage as seen in the attached photos.Based on the details of the complaint and investigation results there is no indication that the damage to the product was caused by the manufacture of the product or left the site of manufacture with this type of damage.Although the complaint has confirmed that the damaged did occur there is no evidence to suggest the damage occurred at the time of manufacture.The most probable root cause would be shipping damage or handling damage after the drain left the site of manufacture.
Event or Problem Description
N/a.

• Brand Name: DRAINS OCEAN SINGLE
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 11269317
• Report Number: 3011175548-2021-00120
• Device Sequence Number: 17013881
• Product Code: KDQ
• UDI-Device Identifier: 00650862100105
• UDI-Public: 00650862100105
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2021

1 Device was Involved in the Event

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: 10/12/2023
• Device Model Number: 2002-300
• Device Catalogue Number: 2002-300
• Device Lot Number: 464074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 02/15/2021; 10/20/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/19/2021; 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1