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

Model Number	4000-100N
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 upon opening the drain, a brown dot was noticed on the plastic holder that attaches the syringe to the product.
Additional 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
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8489066
• Report Number: 3011175548-2019-00363
• Device Sequence Number: 1253413
• Product Code: CAC
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

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: 10/26/2021
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Device Lot Number: 436669
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1