MAUDE Adverse Event Report: BOUND TREE MEDICAL, LLC CURAPLEX 51161 NASOPHARYNGEAL AIRWAY LATEX-FREE; AIRWAY, NASOPHARYNGEAL

Model Number	51154-51161
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
I manage quality assurance for the fire department based paramedic units in (b)(6).We had a nasopharyngeal airway backwards into the oropharyngeal space.The ems crew placed two nasopharyngeal airways on a cardiac arrest patient (routine), and when they later placed a king airway, they were unable to get a definitive etc02 reading.They then pulled the king and discovered the npa had displaced backward and was blocking the king from sealing properly.Thus is not the first time this has happened.The hospital contacted the fire department previously to report a similar incident on (b)(6) 2018.(note--the case was 8 months prior and we were unaware until the other case was reviewed).The icu staff was unable to clear the patients gurgling respirations through suctioning, and discovered a similarly displaced npa 10 days after admission.Upon investigation, it was noted that the clear curaplex npas that we were getting through bound tree have a much smaller flange than previous suppliers.We are pulling the curaplex npas from service to the extent that we have other options available.It is our opinion that the displaced npa could conceivably entirely obstruct the patient's airway.Fda safety report id # (b)(4).

• Brand Name: CURAPLEX 51161 NASOPHARYNGEAL AIRWAY LATEX-FREE
• Common Device Name: AIRWAY, NASOPHARYNGEAL
• Manufacturer (Section D): BOUND TREE MEDICAL, LLC
• MDR Report Key: 8759793
• Report Number: MW5087837
• Device Sequence Number: 19204864
• Product Code: BTQ
• UDI-Device Identifier: 00817617025780
• UDI-Public: (01)00817617025780(10)1502181(17
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/28/2019

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: 07/31/2021
• Device Model Number: 51154-51161
• Device Catalogue Number: 51158
• Device Lot Number: 1501518
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 104