MAUDE Adverse Event Report: ATRIUM MEDICAL EXPRESS SINGLE DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 4000-100N

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Information (3190)

Event Date 06/11/2018

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 that a small hole was found on the inner package, which questioned product sterility.

Manufacturer Narrative

The returned device was evaluated to determine the cause of the pin hole in the blue csr wrap that covers the drain prior to being sealed in the pouch.The csr wrap was opened up evenly and the hole was located easily as the institution circled it with a pen the drain packaging was then re-wrapped to determine where in the package the hole had generated from.Once the drain was re-wrapped it was then placed back inside the sterile pouch that was also provided with the return.The pin hole was located approximately 2 inches below the top of the drain seal on both the csr wrap and the sterile barrier pouch.The hole appears to be a puncture from the outside of the package to the inside.It is difficult to determine when this damage may have occurred but is likely from after the packaging process.Both the csr wrap and sterile pouches are inspected for damage prior to packaging.Based on the investigation of this device, the damage most likely occurred outside the controls of atrium medical during shipping or handling of the device after being distributed to the institution.The instructions for use (ifu) states do not use if the device or package is damaged.The express chest drain system is indicated for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also helps to facilitate postoperative collection and reinfusion of autologous blood from the patient¿s pleural cavity or mediastinal area.The express drain is packaged sterile, or is packaged in a sterile fluid path format (only the contents of the sterile patient tube pack can be entered into the sterile field).This chest drain is for single patient use only.A package that is damaged would be noticed prior to admission to a sterile field.Damaged packaging may be the result of improper storage conditions or shipping occurrences.

• Brand Name: EXPRESS SINGLE DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7709822
• MDR Text Key: 114942891
• Report Number: 3011175548-2018-00728
• Device Sequence Number: 1
• Product Code: CAC
• 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
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2021
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Device Lot Number: 426333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Date Manufacturer Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1