MAUDE Adverse Event Report: AVANOS MEDICAL INC. TURBO-CLEANING CLOSED SUCTION CATHETER, DOUBLE SWIVEL ELBOW - ADULT; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	22716-4J
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
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 not possible as no lot number was provided.All information reasonably known as of 17 may 2024 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.
Event or Problem Description
Per google translate: it was reported, the irrigation port broke, no patient harm reported.Additional information received 02may2024 reported, (per google translate): the device was established on the patient on (b)(6) 2024, on (b)(6) 2024, a clinical engineer (who was performing rounds) discovered a broken valve in one of the track cares; the flapper valve was torn off and fell on the catheter mount side.It was additionally reported, prior to the incident, the staff had been able to perform suction and catheter cleaning without any problems, there was no injury to the patient.
Additional Manufacturer Narrative
Additional information: d4; d9 correction: g4 the product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 18 jun 2024 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.
Additional Manufacturer Narrative
Additional information: d4.Correction: d4.The actual sample from the reported event was returned for evaluation: a flex connector was received attached onto the ¿dse¿, sans the flapper valve.Visual examination of the device, prior to decontamination revealed, the flapper valve component was detached.After decontamination, the returned component was viewed under magnification (30x); the location where the flapper valve should have been located was observed and an obvious breaking effect was seen on the ¿dse¿ area with some residue of the flapper valve component still visible.The reported event could be confirmed as reported; however, the root cause is undetermined.The device history record for lot 20108811 was reviewed and the product was produced according to product specifications.All information reasonably known as of 21 feb 2025 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: TURBO-CLEANING CLOSED SUCTION CATHETER, DOUBLE SWIVEL ELBOW - ADULT
• 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: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 19350665
• Report Number: 8030647-2024-00039
• Device Sequence Number: 7147710
• Product Code: BSY
• UDI-Device Identifier: 00609038994307
• UDI-Public: (01)00609038994307(10)20108811(17)280423(11)230502
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2025

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: 22716-4J
• Device Catalogue Number: 22716-4J
• Device Lot Number: 20108811
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 06/05/2024; 01/31/2025
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/24/2024; 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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