MAUDE Adverse Event Report: AVANOS MEDICAL INC. ORAL CARE SUCTION SWAB, ANGLED-TIP; VAP ORAL CARE PRODUCTS

Model Number	12603
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	Erosion (1750)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 15 jan 2019 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the foam on the suction swabs changed positioning on the plastic, which results in stronger suction into the patient's mucosal oral cavities.This has led to lesions which were serious and required medical intervention.Per additional information received 15 jan 2019, the patient had "heavily bleeding ruptures", and "an ear / nose / throat specialist had to obliterate the wounds.".
Additional Manufacturer Narrative
Correction: per communication with the customer, the returned sample was not the correct sample, and was not involved in the reported event.No sample has been returned for the reported event.The device history record for lot m18156a509 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 13 feb 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 halyard health 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.Device not returned.

• Brand Name: ORAL CARE SUCTION SWAB, ANGLED-TIP
• Common Device Name: VAP ORAL CARE PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8253471
• Report Number: 8030647-2019-00011
• Device Sequence Number: 2189745
• Product Code: BSY
• UDI-Device Identifier: 30609038093094
• UDI-Public: 30609038093094
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 12603
• Device Catalogue Number: 991096897
• Device Lot Number: M18156A509
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention