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

Model Number 4000-100N

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that upon opening the drain, a brown dot was noticed on the plastic holder that attaches the syringe to the product.

Manufacturer Narrative

Analysis: as the express chest drain was not returned a thorough investigation could not be performed.There was also no image provided of the brown dot that was found within the package.A review of the manufacturing packaging procedure shows that there are two 100% inspections conducted for particulate during the process of packaging the chest drain.The first 100% particulate inspection conducted is during the blue csr wrapping process and the second 100% inspection is conducted just prior to the pouching sealing process.A review of the scrap reason codes within the device history records also show that there were no devices rejected during the manufacture or inspection of the express chest drain for brown spots being present.Conclusion: based on the investigation atrium medical corporation cannot conclude that the brown spot was present in the package prior to the institution opening the sealed pouch of the chest drain.All chest drains are manufactured and packaged within a clean room environment where all efforts are made to ensure that the chest drains are clean and free of particulate of any kind.

• Brand Name: EXPRESS SINGLE CHEST DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8489066
• MDR Text Key: 141312372
• Report Number: 3011175548-2019-00363
• 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: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2021
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Device Lot Number: 436669
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1