MAUDE Adverse Event Report: AMBU, INC. AMBU AURASTRAIGHT; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Catalog Number 324 100 000U

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Respiratory Distress (2045); Sweating (2444); Respiratory Failure (2484)

Event Date 05/26/2016

Event Type  malfunction  

Event Description

The patient is a newborn with a retained foreign body (tip of an lma (laryngeal mask airway)) in the oropharynx leading to respiratory distress.The patient was born at home.He developed respiratory failure and thus ems was called.He was transferred to er and then an outside hospital where he was intubated on day of life (b)(6).He was then transferred to this facility for further management.He self extubated and an lma was used to ventilate the patient.The lma was removed and he was intubated.He required vv ecmo for 4 days.He was extubated to nasal cpap, but shortly thereafter developed worsening respiratory distress and was re-intubated approximately 3 days later.He was successfully extubated again about 2 days later.Otolaryngology was consulted on the same day due to increased work of breathing and increased secretions.No foreign body was identified at that time.The following day, there was suspicion of a plastic foreign body and so otolaryngology was again contacted.There was a large clear plastic piece that was retained from the lma that was plastered against the entire posterior and lateral pharyngeal walls.This was removed and the patient's secretions and respiratory needs improved immediately.In summary this newborn who had a retained large piece of an lma in his airway (oropharynx) for approximately 18 days.This was missed on 2 dls (direct laryngoscopies) and 1 flexible laryngoscopy.This may have contributed to his failed extubation and was causing distress when i saw him.Additional notes: hands on care initiated at 2100.Infant crying and diaphoretic with large amount oral secretions visualized.Mouth suctioned and postural drainage and percussion (pd&p) started.Infant continued to cry with gurgling noted, mouth suctioned again and pacifier offered to help soothe.Infant continued to cry with audible stridor and increased retractions.Back of mouth suctioned with yellow neosucker.While suctioning back of the mouth, this rn noticed what appeared to be white plastic to the back of the mouth at the palatine tonsils bilaterally.Upon further inspection with penlight, foreign object was better visualized and appeared to circle from palatine tonsils to back of the throat.Medical team called to bedside to evaluate.Neonatal medical team at bedside.What appeared to be a plastic object was visualized by nnp and md.Attending physician was called to bedside.Md attempted to remove object with tweezers but was unsuccessful.Ent paged to bedside.2145, ent resident arrived at bedside and was able to visualize object during oral inspection with tongue depressor.Beside scope done through nose and was visualized again.Md called fellow ent resident to bedside to evaluate.Second ent resident arrived at bedside at 2230.Md was able to remove object with hemostat clamp at 2245.Infant tolerated procedure well, hr and o2 sats wnl on ram cannula.Small amount of bleeding noted when object removed, cleared with oral suction.Foreign object found to be cap of lma.Repeat scope preformed to evaluate for airway swelling and bleeding.Decadron course ordered.After removal of object, stridor and copious oral secretions dramatically improved.Infant resting comfortably on back without any evidence of respiratory distress.Additional notes: nicu team were called to the bedside for suspected foreign object in the mouth noticed by the nurse.We evaluated and partially saw a clear plastic piece in the oropharynx.We called ent to the bedside who visualized and removed the foreign object.It was a case to an lma that was placed weeks before.The patient tolerated this process well.

• Brand Name: AMBU AURASTRAIGHT
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): AMBU, INC.; 6230 old dobbin ln ste. 250; columbia MD 21045
• MDR Report Key: 5846271
• MDR Text Key: 51155698
• Report Number: 5846271
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2016,07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 324 100 000U
• Device Lot Number: 1689216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other