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

Model Number 2270135

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 (b)(6) 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.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).

Event 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 second of five reports.Refer to 8030647-2020-00092 for the first 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.There was no reported injury.

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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: BALLARD TURBO CS ADULT, 14 FR, T-PIECE
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10870626
• MDR Text Key: 226563322
• Report Number: 8030647-2020-00093
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 00609038947013
• UDI-Public: 00609038947013
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2020
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1