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 Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a hair was found inside the sterile packaging prior to use.No impact to the patient.

Event Description

N/a.

Manufacturer Narrative

Analysis: the returned express chest drain was removed from the outer packaging.There was a large hair on the outer bag in which the drain was shipped.The bag was removed and the drain removed.The drain was in the original package that had been opened.There was a small piece of hair stuck to a piece of tape that was placed by the institution.The details of the drain indicate that the hair was noticed in the sealed drain.Unfortunately the drain has been opened and there is no way to confirm that the hair was introduced prior to the final packaging sealing operation or if it was introduced in the field when the drain was opened.A review of the manufacturing packaging procedure mp009267 rev ad 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.Based on the details within the inspection process hairs of any kind are not allowed.A review of the scrap reason codes within the device history records also show that there were no devices reject during the manufacture or inspection of the express chest drain lot in question for hair being present in the packaging materials.Conclusion: based on the investigation atrium medical corporation cannot conclude that the hair was present in the package prior to the institution opening the sealed pouch of the chest drain or fell into the pouch upon opening the sealed pouch at the institution.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 loose fibers or hairs.The procedure for gowning prior to entering the clean room requires all staff members to be suited in a one piece full body gown with two separate bouffant caps that cover all hair and beard covers if required and full foot coverage booties.

• 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: 8451983
• MDR Text Key: 139970747
• Report Number: 3011175548-2019-00311
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2021
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Device Lot Number: 433684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1