MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION EXPRESS SINGLE DRIAN; CHEST DRAIN

Model Number 4000-100N

Device Problems Leak/Splash (1354); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report stated they had an express drain and upon use it kept showing a persistent air leak, they clamped tube, swapped out the drain to trouble shoot and found that the drain was missing the o-ring.

Manufacturer Narrative

Device history record review was performed and found to have met specifications.The product was not returned so an evaluation of the device for the source of the air leak could not be performed.The in-line connector (ilc) was disconnected by the user and the user alleged that the o-ring connector was missing, however, as the product was not returned the source of the air leak could not be confirmed.There have been no other reports for this failure mode on this lot.Other potential sources for air leak are system-related (catheter eyelet close to surface, poor connection between catheter and patient tubing, etc).

• Brand Name: EXPRESS SINGLE DRIAN
• Type of Device: CHEST DRAIN
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054-4929 ; 6038645366
• MDR Report Key: 5021826
• MDR Text Key: 24682018
• Report Number: 1219977-2015-00238
• Device Sequence Number: 1
• Product Code: CAC
• 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: company representative,health
• Reporter Occupation: Other
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/31/2018
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Device Lot Number: 222517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 106