MAUDE Adverse Event Report: HALYARD HEALTH MICROCUFF ENDOTRACHEAL TUBE FOR PEDIATRICS, 4.5 MM, ORAL CURVED; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35164
Medical Device Problem Code	Detachment Of Device Component (1104)
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.The device history record for lot cm7361002 was reviewed and the product was produced according to product specifications.All information reasonably known as of 26 jun 2018 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 halyard health 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 halyard health.Halyard health 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).Device not returned.
Event or Problem Description
It was reported that the pilot line on the microcuff came away from the tube during extubation.It remained in the mouth when the tube was removed.The pilot line was removed intact, but a direct laryngoscopy was performed to ensure there was nothing left in the airway.No further information has been provided at this time.
Additional Manufacturer Narrative
All information reasonably known as of 02 jul 2018 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 halyard health 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 halyard health.Halyard health 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 a halyard health product is defective or caused serious injury.
Event or Problem Description
Per additional information received 25 jun 2018, the patient has been discharged from the hospital.
Additional Manufacturer Narrative
One sample was received for evaluation.The sample was received with the inflation line detached from the tubing.The area of separation was examined under magnification.The endotracheal tube skive which receives the inflation line had a jagged fragment of the inflation line inside.The inflation line was severed flush with the skive opening.Under uv light, both the inflation line and the skive fluoresce, indicating that the bonding agent containing adhesive brightener was present.No root cause could be determined.All information reasonably known as of 04 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.

• Brand Name: MICROCUFF ENDOTRACHEAL TUBE FOR PEDIATRICS, 4.5 MM, ORAL CURVED
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7652948
• Report Number: 3011270181-2018-00020
• Device Sequence Number: 11207971
• Product Code: BTR
• UDI-Device Identifier: 10680651351644
• UDI-Public: 10680651351644
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2019

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 Expiration Date: 12/27/2022
• Device Model Number: 35164
• Device Catalogue Number: 991035164
• Device Lot Number: CM7361002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 06/25/2018; 01/10/2019
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 07/02/2018; 02/05/2019
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 18