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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
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 15 feb 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 complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the in-line suction was not suctioning, on the closed suction catheter (csc) during use; there was no reported injury.Additional information received 14feb2022 reported the incident occurred during the initial use/placement of the csc on the patient, and the csc was immediately replaced for a new one.There was no reported injury.
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 15 feb 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.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 complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the in-line suction was not suctioning, on the closed suction catheter (csc) during use; there was no reported injury.Additional information received 14feb2022 reported the incident occurred during the initial use/placement of the csc on the patient, and the csc was immediately replaced for a new one.There was no reported injury.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 13 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 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: 13535623
• Report Number: 8030647-2022-00053
• Device Sequence Number: 14469048
• Product Code: BSY
• UDI-Device Identifier: 00609038939070
• UDI-Public: 00609038939070
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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 Model Number: 2210
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown