MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS DOUBLE; APPARATUS, AUTOTRANSFUSION

Model Number 3620-100

Device Problem Material Puncture/Hole (1504)

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

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on opening the product the customer found a hole in the inner and outer drape.

Manufacturer Narrative

Analysis: the oasis chest drain was not returned and no images of the hole in the inner and outer drape were obtained.Without the drain in question atrium medical cannot confirm the complaint.The manufacturing procedure requires the following in regards to inspecting the drape otherwise known as csr wrap for every chest drain manufactured.Arrange csr wrap at workstation using the diamond shaped layout shown below.Leave one corner of the wrap draped over the table between the operator and workstation as shown.Inspect the csr wrap for uniform color (blue), tears, grease, pinholes and particulate.Embedded particulate: must not exceed 0.8mm2, as measured with a tappi chart (refer to tp009200 for usage instructions).Note: embedded particulate may not exceed more than three (3) per in2 or a total of nine (9) per device.Loose particulate: loose particulate may not exceed 0.40 mm2, as measured with a tappi chart (refer to tp009200 for usage instructions).Note: loose particulate smaller than 0.40 mm2 may not exceed more than three (3) pieces per device.Conclusion: based on the results of the investigation atrium medical corporation cannot conclude that there was a pin hole in the blue csr wrap without the actual device in question.Atrium medical corporation inspects every csr wrap prior to wrapping the drain.If there was a hole in the csr wrap the integrity of the product would still be intact and the drain still sterile.If the outer protective pouch had been punctured as well then the device would no longer be sterile.There was no mention in the reported details that the outer sterile barrier had been compromised.H3 other text : device not returned.

Event Description

N/a.

Manufacturer Narrative

Correction section b.3.

Event Description

N/a.

• Brand Name: DRAINS OASIS DOUBLE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8716588
• MDR Text Key: 148567481
• Report Number: 3011175548-2019-00705
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862112016
• UDI-Public: 00650862112016
• 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,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2022
• Device Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Device Lot Number: 443594
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other