MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. NASAL AIRWAY LATEX FREE 36F; AIRWAY, NASOPHARYNGEAL

Catalog Number	123136
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The medwatch report states."patient was in the care of ems and presenting with seizure like activity when a robertazzi nasopharyngeal airway was placed.Upon arrival at hospital physician began to initiate intubation and noted the nasopharyngeal airway had become lodged in the vocal cords." no patient harm or injury."the physician used the video laryngoscopy in order to locate the nasal pharyngeal trumpet which was passing the cords.Kelly clamps were used to remove the trumpet and facilitate the intubation.No additional or excessive force was used while placing the npa.Patient became combative while care was rendered.Patient was transferred to the micu and successfully extubates and discharged on (b)(6) 2023.".
Additional Manufacturer Narrative
Qn#(b)(4).Medwatch #mw5118975 other remarks: n/a corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The medwatch report states."patient was in the care of ems and presenting with seizure like activity when a robertazzi nasopharyngeal airway was placed.Upon arrival at hospital physician began to initiate intubation and noted the nasopharyngeal airway had become lodged in the vocal cords." no patient harm or injury."the physician used the video laryngoscopy in order to locate the nasal pharyngeal trumpet which was passing the cords.Kelly clamps were used to remove the trumpet and facilitate the intubation.No additional or excessive force was used while placing the npa.Patient became combative while care was rendered.Patient was transferred to the micu and successfully extubates and discharged on (b)(6) 2023.".

• Brand Name: NASAL AIRWAY LATEX FREE 36F
• Common Device Name: AIRWAY, NASOPHARYNGEAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 17407205
• Report Number: 8040412-2023-00301
• Device Sequence Number: 7357798
• Product Code: BTQ
• UDI-Device Identifier: 04026704300884
• UDI-Public: 04026704300884
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2024
• Device Catalogue Number: 123136
• Device Lot Number: 20A09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown