MAUDE Adverse Event Report: HALYARD HEALTH MICROCUFF* ENDOTRACHEAL TUBE FOR ADULTS, 6.0 MM, ORAL/NASAL; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35212
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Hypoxia (1918); Low Oxygen Saturation (2477)
Date of Event	07/03/2017
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 in-progress.All information reasonably known as of (b)(6) 2017 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.Device not returned.
Event or Problem Description
User facility report number ¿ (b)(4) was received on (b)(6) 2017.Per report by trauma icu (ticu) rn: "intubated patient suddenly desaturated to 75%.Ultimately, the decision was made for anesthesia to exchange the et tube.Rn reports concerns for cuff leaks: product with suspected cuff leaks." additional information was received on (b)(6) 2017 that states the tube was changed immediately when the patient had desaturation of 75%.No additional information was provided.
Additional Manufacturer Narrative
The device history record for the lot number, um6046xxx, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.A root cause could not be determined.All information reasonably known as of 27sep2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
Event or Problem Description
Additional information received 08-sep-2017 from the customer that states,the incident event date for (b)(4) is (b)(6) 2017.Additional information was received on 11-sep-2017 from the customer that states, "i sent a request to the fda to amend the date of event to (b)(6) 2017 on report number (b)(4)." the customer does not know how long the product was in use and the response was "unknown." the customer also reported "unknown" and did not know if the patient's oxygen saturation stabilized with the tube change.No additional information was reported.

• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6837200
• Report Number: 9611594-2017-00124
• Device Sequence Number: 13467886
• Product Code: BTR
• UDI-Device Identifier: 30680651352126
• UDI-Public: 30680651352126
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K113333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2017

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: Nurse
• Device Expiration Date: 02/01/2021
• Device Model Number: 35212
• Device Catalogue Number: 991035212
• Device Lot Number: UM6046XXX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 09/28/2017
• Patient Sequence Number: 1
• Patient Age: 22 YR