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

Model Number	4000-100N
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
It was reported that the chest drain tube and connector did not fit the 20fr trocar uses as the trocar was the same size as the chest drain tube.The product was not defective, however the components provided were not adequate.
Additional Manufacturer Narrative
Analysis: the details provided indicate that the express chest drain tube and connector did not fit the 20fr trocar as the trocar was the same size as the chest drain tube.The product was not defective, however the components provided were not adequate.The express chest drain is provided with a standard connector at the end of the patient line.It is up to the institution to determine what size connectors the hospital inventory should carry to ensure they have the proper fittings for the multitude of trocar catheters available.Atrium medical corporation provides a complete list of accessories available for use with the complete line of chest drains.Conclusion: based on the results of the investigation the proper connector was provided with the express chest drain and has not changed.H3 other text : not returned.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Corrected b3.

• Brand Name: DRAINS EXPRESS SINGLE
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8851034
• Report Number: 3011175548-2019-00827
• Device Sequence Number: 13806129
• Product Code: KDQ
• UDI-Device Identifier: 00650862115130
• UDI-Public: 00650862115130
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043140
• 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): 08/01/2019

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: 02/28/2019
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Device Lot Number: P14287
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 08/23/2019; 02/01/2021
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 09/04/2019; 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention