MAUDE Adverse Event Report: AVANOS MEDICAL INC. AVANOS ORAL CARE SUCTION TIP YANKAUER WITH AVANOS TECHNOLOGY, ANGLED; VAP ORAL CARE PRODUCTS

Model Number	12604
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Airway Obstruction (1699)
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 not possible as no lot number was provided.All information reasonably known as of 13 dec 2019 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 tip of the device came away in the patient's mouth and was retrieved.Per additional information received 3 dec 2019, the patient started making gargling sounds.A laryngoscopy was performed and the doctor found an oral suction catheter tip in the back of the patient's throat.The tip was confirmed not to be from the patient's current suction catheter in use.Forceps were used to remove the tip.Per additional information received 13 dec 2019, the tip was confirmed to be from the yankauer.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 31 jan 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 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
One partial sample was received for evaluation.The sample appeared to be part of the suction swab tip.Visual examination revealed that there was jagged breaking on one side, with stress whitening.There were also surface indentations on the outer wall.The complaint is confirmed and the root cause was potentially manufacturing related.All information reasonably known as of 27 apr 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 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: AVANOS ORAL CARE SUCTION TIP YANKAUER WITH AVANOS TECHNOLOGY, ANGLED
• Common Device Name: VAP ORAL CARE PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9472800
• Report Number: 8030647-2019-00107
• Device Sequence Number: 2648746
• Product Code: JOL
• UDI-Device Identifier: 30680651968983
• UDI-Public: 30680651968983
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2020

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: 12604
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 01/15/2020; 04/27/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/01/2020; 04/27/2020
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 100