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

Model Number	13223
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2018
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 not possible as no lot number was provided.All information reasonably known as of (b)(6) 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 "a patient was intubated with an 8.0 microcuff that kept coming apart where the tube connects to the blue connector and then to the ventilator circuit.The end of the subglottic microcuff endotracheal tube (et) became stretched out.Initially the staff pulled another 8.5 connector from another new tube to improve the fit, but that solution failed.Ultimately the anesthesiologist used a suture thread to wrap around the end of the et tube and tied a knot to the blue connector.No harm to the patient as a result.".
Additional Manufacturer Narrative
The actual complaint product is not available for evaluation.All information reasonably known as of 27mar2018 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).
Event or Problem Description
Additional information was received 01-mar-2018 that states, no samples are available for this report.No additional information was provided.

• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7359280
• Report Number: 9611594-2018-00034
• Device Sequence Number: 581106
• Product Code: BTR
• UDI-Device Identifier: 10680651132236
• UDI-Public: 10680651132236
• 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): 03/01/2018

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 Model Number: 13223
• Device Catalogue Number: 991013223
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 03/29/2018
• Patient Sequence Number: 1