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

Model Number 3600-100

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The white graduated tip that goes to the chest tube from the atrium (where the zip tie goes) came out of the package shattered.No damage to the package.

Event Description

N/a.

Manufacturer Narrative

Corrected information: section e1 - initial reporter h3 other text : device not available for return.

Manufacturer Narrative

Investigation: this complaint reports that the barbed connector was "shattered" when it was removed from the package of an oasis drain (p/n 3600-100) and that there was no damage to the packaging.Multiple attempts were made to acquire more information from the customer.The customer responded that the device had been discarded and would not be returned.They did not provide any images of the damaged device.A likely cause of this complaint could not be identified.The supplier performs 100% inspection of these parts and provides them as part of the patient line assembly, with a white cap covering them.If damage occurred to the connector at the supplier facility, it would have been caught and rejected during their inspection.If damage occurred to the connector on route to getinge, damage to the packaging or cap would have been present during incoming inspection and the assembly would have been rejected.There are no steps in getinge's manufacturing process which would apply the amount of force necessary to damage the connector in this way, particularly because no damage was reported to the cap covering the connector or to the csr wrap or packaging.It is unlikely that this kind of damage could occur during shipping without noticeable damage also being done to the packaging and cap.For these reasons, the root-cause of this complaint is impossible to define.A dhr review was completed which found no anomalies in the manufacturing process.The ifu provides adequate instructions for the setup of the device and instructs the user not to use the device if it is damaged.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found three similar complaints of damaged barbed connectors.These complaints were all received from the same customer and were all for the same lot (a different lot than this complaint).The investigation concluded that the damage was very unlikely to have occurred at getinge or with the supplier of the connector, however a root-cause could not be identified.A recurring lot number report was completed which found no other complaints involving lot 489752.A review of cars/capas found none related to this complaint.A scar review found none related to this complaint.A ncr review found no ncrs related to this investigation.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.Because the device was not returned and no images or any other evidence of the incident was provided, this complaint cannot be confirmed.A device nonconformity cannot be confirmed with the provided information or with the information reviewed in this investigation.The root-cause of this complaint is impossible to define.

Event Description

N/a.

• Brand Name: DRAINS OASIS 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 Key: 16303010
• MDR Text Key: 309376181
• Report Number: 3011175548-2023-00048
• Device Sequence Number: 1
• Product Code: KDQ
• 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,Followup
• Report Date: 03/24/2023

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 Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 489752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 02/14/2023; 03/24/2023
• Supplement Dates FDA Received: 02/14/2023; 03/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1