MAUDE Adverse Event Report: TELEFLEX PVC NASOSPHARYNGEAL AIRWAY

Model Number 123328

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/11/2015

Event Type  Injury  

Event Description

After ischiorectal abcess repair surgery, at time if emergence from anesthesia, pt was extubated when pt seemed strong and awake.The pt did not breathe.Anesthesiologist attempted to place nasal airway through the right nostril.This immediately caused a massive epistaxis.Pt has an oral airway placed and then ventilated with bag and mask.Pt has to be reintubated.Pt has to be taken to icu to sedate pt, watch airway and epistaxis until he awakened again to electively extubate in a controlled setting.Anesthesia concerned about the rigidity of the nasal airway material.

• Brand Name: PVC NASOSPHARYNGEAL AIRWAY
• Type of Device: PVC NASOSPHARYNGEAL AIRWAY
• Manufacturer (Section D): TELEFLEX; kamuntin, perak ; MY
• MDR Report Key: 5161778
• MDR Text Key: 28838182
• Report Number: MW5057211
• Device Sequence Number: 1
• Product Code: CAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2019
• Device Model Number: 123328
• Device Catalogue Number: 123328
• Device Lot Number: 14IE38
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 177