MAUDE Adverse Event Report: TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	227
Medical Device Problem Codes	Suction Problem (2170); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 01 jul 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Avanos medical inc.Received a single report that referenced five different incidences, which were associated with separate units, involving five different patients.This is the third of five reports.Refer to 8030647-2020-00038 for the first report.Refer to 8030647-2020-00039 for the second report.Refer to 8030647-2020-00041 for the fourth report.Refer to 8030647-2020-00042 for the fifth report.It was reported that the "et [endotracheal] tube [ett] clogged with tenacious secretions." no specific information was provided for this patient.Additional information was received 16-jun-2020.The user facility stated "you can hear the secretions 'rattling' even though you have just or in the process of suctioning.In some instances they don't get anything out but can hear it.Sometimes they will remove the patient from the vent and straight cath them to get the secretions.In some instances when we are not getting the secretions the xray is not improving and o2 [oxygen] requirements not improving they will bronch [bronchoscopy] the patients and will get tons of secretions with plugs.".

• Brand Name: TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10217909
• Report Number: 8030647-2020-00040
• Device Sequence Number: 2404828
• Product Code: BSY
• UDI-Device Identifier: 00609038938394
• UDI-Public: 00609038938394
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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 Model Number: 227
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/01/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1