MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CATH-GUIDE AIRWAY,100MM; AIRWAY, OROPHARYNGEAL, ANESTHE

Model Number IPN049856

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (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 Description

It was reported that "when the doctor intubated the patient to suck sputum, he found that the resistance in the cavity was large, and it was difficult to insert the suction tube.No impact on patient".No injury or harm reported.Patient condition reported as "fine".

• Brand Name: HUDSON CATH-GUIDE AIRWAY,100MM
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 12245753
• MDR Text Key: 264079476
• Report Number: 3004365956-2021-00237
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 14026704646491
• UDI-Public: 14026704646491
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2021

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
• Device Operator: Health Professional
• Device Model Number: IPN049856
• Device Catalogue Number: 1167
• Device Lot Number: 74F2000055
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1