MAUDE Adverse Event Report: BALLARD TURBO CS ADULT, 14 FR, T-PIECE; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	2270135
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 19-nov-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 comp (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 events.This is the first of five reports.Refer to 8030647-2020-00093 for the second event.Refer to 8030647-2020-00094 for the third event.Refer to 8030647-2020-00095 for the fourth event.Refer to 8030647-2020-00096 for the fifth event.It was reported the closed suction catheter was popping off the trach during use and popped off during use on a covid-19 patient.There was no reported injury.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30059295, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 04-jan-2021 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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).

• Brand Name: BALLARD TURBO CS ADULT, 14 FR, T-PIECE
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10870668
• Report Number: 8030647-2020-00092
• Device Sequence Number: 11478843
• Product Code: BSY
• UDI-Device Identifier: 00609038947013
• UDI-Public: 00609038947013
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 04/30/2025
• Device Model Number: 2270135
• Device Catalogue Number: N/A
• Device Lot Number: 30059295
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 01/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1