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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION DRAINS OCEAN SINGLE; BOTTLE, COLLECTION, VACUUM Back to Search Results
Model Number 2002-300
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2022
Event Type  malfunction  
Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
 
Event Description
When the patient got out of bed and moved around after the operation, the connect site between the chest drainage and the tissue cracked.Then the doctor changed another one instead.
 
Manufacturer Narrative
It was reported that the catheter connecting the drain to the patient cracked near its connection to the drain.When follow-up information was requested, the customer reported that the catheter was a local brand (in china) and the size was 16 fr.They confirmed that there was no damage to the drain and they did not report any malfunction other than the physical damage to the catheter.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.The information provided by the customer indicates that the device was used with a smaller catheter than it is recommended for and they confirmed that there was no malfunction with the drain.Therefore, the root-cause of this issue is operational context.The device history record was reviewed and found no nonconformities or anomalies in its manufacturing.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.A complaint history review was completed which found no related complaints.A review of ncrs and capas were able to rule out any related issues and there were no other complaints received for the affected 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.H3 other text : device not available for return.
 
Event Description
Additional information reported stated that the drain was functioning properly before the event occurred.
 
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Brand Name
DRAINS OCEAN 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 Key15362165
MDR Text Key304103165
Report Number3011175548-2022-00253
Device Sequence Number1
Product Code KDQ
UDI-Device Identifier00650862100105
UDI-Public00650862100105
Combination Product (y/n)N
PMA/PMN Number
K043140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/16/2022
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
Device Operator Health Professional
Device Expiration Date10/14/2022
Device Model Number2002-300
Device Catalogue Number2002-300
Device Lot Number451409
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/24/2022
Initial Date FDA Received09/06/2022
Supplement Dates Manufacturer Received09/06/2022
Supplement Dates FDA Received11/17/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/18/2019
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age11 YR
Patient SexMale
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