MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-5.6-4.0-12; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35111
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 16 oct 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 avanos medical complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the cuff broke.Per additional information received 01 oct 2019, there was no injury to the patient.Per additional information received 08 oct 2019, the incident occurred on the third day after intubation.The patient was to be extubate at that time, so the microcuff and tested for leaks.A pinhole leak was discovered in the middle of the cuff.The cuff pressure was 20cm h2o.
Additional Manufacturer Narrative
One used sample was received for evaluation.The sample appeared generally clean inside and outside of the tubing and cuff.The balloon cuff was filled with water and leakage was observed on both sides of the cuff material.When viewed under magnification the balloon cuff exhibited lines which look similar to perforated line and scratch marks.A tiny hole was observed in the area where the lines in the balloon cuff were located.The complaint is confirmed as reported, however, no root cause could be determined.All information reasonably known as of (b)(6) 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).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 product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of (b)(6) 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).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: MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-5.6-4.0-12
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9204347
• Report Number: 3011270181-2019-00059
• Device Sequence Number: 2950928
• Product Code: BTR
• UDI-Device Identifier: 10680651351118
• UDI-Public: 10680651351118
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2019

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: 35111
• Device Catalogue Number: 103511101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 10/23/2019; 12/04/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/14/2019; 12/16/2019
• Patient Sequence Number: 1