MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CS ADULT, 14 FR, DSE; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	2210
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 24-feb-2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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
It was reported the closed suction catheter was not working as well.The "button" does not create suction when pressed.There was no reported injury.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 21-mar-2022 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.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30145559, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The sample was received without the entire closed suction assembly.Only the thumb valve body portion was received.The manifold area and the rest of the catheter body was not returned.No original packaging was returned.The device was evaluated.The thumb valve was pressed and released multiple times for functional inspection.Each time after release, the thumb valve returned to the upright position.The thumb valve was also inspected if the rotation was possible, multiple times (three times), the thumb valve was rotated from the unlocked to locked position and there were no difficulties or issues seen.The sample was then attached to mobivac suctioning equipment with the suction set at 120mmhg.Upon connection, while still engaged with the mobivac system, the distal end of the catheter was inserted in a beaker of water with blue dye.The suctioning occurred when the thumb valve was pressed.The thumb valve was turned into locked position.The suctioning did not occurred when the valve was placed in the locked position.Root cause could not be determined.All information reasonably known as of 29-apr-2022 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 CS ADULT, 14 FR, DSE
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13609156
• Report Number: 8030647-2022-00068
• Device Sequence Number: 5834306
• Product Code: BSY
• UDI-Device Identifier: 00609038939070
• UDI-Public: 00609038939070
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2022

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: 07/01/2026
• Device Model Number: 2210
• Device Catalogue Number: N/A
• Device Lot Number: 30145559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 03/03/2022; 04/02/2022
• Initial Report FDA Received Date: 02/26/2022
• Supplement Report FDA Received Date: 03/23/2022; 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown