OASIS SINGLE DRAIN 3600-100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-24 for OASIS SINGLE DRAIN 3600-100 manufactured by Atrium Medical Corporation.

Event Text Entries

[188034486] A follow up report will be submitted upon the completion of the investigation into this event.
Patient Sequence No: 1, Text Type: N, H10


[188034487] Hospital reported they had a device leak on set-up. When investigating they observed a crack on the drain body.
Patient Sequence No: 1, Text Type: D, B5


[188145793] A review of the returned drain confirmed the presence of a large crack in the lower front panels of the drain. A crack of the drain of this nature could only be caused by a very blunt force applied such as a drop of the drain or shipping and handling damage. The drains during the process of manufacturing undergo a full system pressure test to ensure the integrity of the drain. A crack of this nature would have easily been detected and rejected by the automated system. This crack is also large enough that the manufacturing operator would have been able to visually see the crack as well. A review of the device history records indicates that the lot of chest drains passed all quality and performance requirements prior to being released. The instruction for use state "do not use if device or package is damaged". Summary/conclusion - based on the results of the investigation the most probable root cause of the cracked oasis chest drains is that the product was damaged while in transit. A large crack would have been noticed during the multiple manufacturing process steps in manufacturing including the 100% product leak test.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3011175548-2020-00315
MDR Report Key9744053
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-24
Date of Report2020-02-24
Date Mfgr Received2020-02-18
Device Manufacturer Date2019-12-02
Date Added to Maude2020-02-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street40 CONTINENTAL BLVD
Manufacturer CityMERRIMACK NH 03054
Manufacturer CountryUS
Manufacturer Postal03054
Manufacturer G1ATRIUM MEDICAL CORPORATION
Manufacturer Street40 CONTINENTAL BLVD
Manufacturer CityMERRIMACK NH 03054
Manufacturer CountryUS
Manufacturer Postal Code03054
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOASIS SINGLE DRAIN
Generic NameAPPARATUS, AUTOTRANSFUSION
Product CodeCAC
Date Received2020-02-24
Returned To Mfg2020-03-06
Model Number3600-100
Catalog Number3600-100
Lot Number452818
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerATRIUM MEDICAL CORPORATION
Manufacturer Address40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.