MAUDE Adverse Event Report: HALYARD HEALTH MICROCUFF* SUBGLOTTIC SUCTIONING ADULT ENDOTRACHEAL TUBE; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	13220
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/26/2018
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 in-progress; a follow-up report will be filed.All information reasonably known as of 21mar2018 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 (b)(4).Device not returned.
Event or Problem Description
It was reported that after a patient was intubated the cuff would not hold air.(new microcuff endotrachael tube was checked and then placed over tube exchanger).After intubation the second microcuff cuff was not holding air.The ett was removed and a tear was found.The anesthesiologist intubating the patient asked if patient had any sharp teeth.Anesthesia was denied and said they had good view.The patient was intubated without microcuff the third time.Additional information was received on 27feb2018 from the customer that stated, an emergent tracheal intubation was done.No additional information was provided.
Additional Manufacturer Narrative
One sample was received.No product packaging was received.The product did not contain a lot number identification.Air was infused into the cuff and immediate leakage occurred.Inflation could not be achieved.The cuff was inspected.The cuff exhibited a large tear, covering most of the cuff on one side.The tear did not extend to either cuff collar.No root cause was identified.All information reasonably known as of 04-may-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).

• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7364295
• Report Number: 9611594-2018-00036
• Device Sequence Number: 113151
• Product Code: BTR
• UDI-Device Identifier: 10680651132205
• UDI-Public: 10680651132205
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K131254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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: Physician
• Device Expiration Date: 07/01/2019
• Device Model Number: 13220
• Device Catalogue Number: 991013220
• Device Lot Number: AA7198V01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 05/08/2018
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 205