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

Model Number 4000-100N

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event 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.

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 Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Corrected b3.

• Brand Name: DRAINS EXPRESS SINGLE
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8851034
• MDR Text Key: 153132482
• Report Number: 3011175548-2019-00827
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862115130
• UDI-Public: 00650862115130
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Device Lot Number: P14287
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 08/23/2019; 02/01/2021
• Supplement Dates FDA Received: 09/04/2019; 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention