MAUDE Adverse Event Report: AMBU A/S AMBU BLUESENSOR R; ELECTROCARDIOGRAPHIC ELECTRODE, SINGLE-USE, PRODUCT CODE: DRX

Catalog Number R-00-S/25

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Foreign Body In Patient (2687)

Event Date 08/31/2019

Event Type  Injury  

Manufacturer Narrative

No sample was returned for investigation.Investigation of failure was done by reviewing the product and its ifu.The product has a clear plastic backing, which should be removed and disposed according to ifu: - dispose of liner/capsule immediately after removal of electrodes.- after removal of electrodes, plastic cover should be disposed of in assigned waste bin.The cause for this incident is due to user mishandling where the user did not dispose the plastic cover immediately to the assigned bin after removal of the electrodes as according to ifu.Then the removal plastic cover accidentally inserted into patient's throat together with laryngeal mask.This product risk analysis has been evaluated as part of the investigation.The risk has been evaluated as acceptable level and does not change the overall conclusion of the risk management report.

Event Description

A clear plastic backing was found in the throat of a patient.It was suspected that the backing was inadvertently inserted into the patient's throat during insertion of a laryngeal mask airway (undertaken by a consultant anesthetist) during surgery on 31/08/2019.The clear plastic backing was suspected to come from ambu ecg electrodes.Post surgery the patient experienced a sore throat, painful on swallowing, despite analgesic medication, an extended course of fungal treatment and a course of antibiotic treatment.During examination 17 days after the surgery, a plastic disc was detected at the base of the tongue.An ent surgeon retrieved the plastic backing with a flexible endoscope.This immediately resolved the patient's symptoms.A small excoriation was found on the patient's left lateral pharyngeal wall, which is expected to heal without problem.

• Brand Name: AMBU BLUESENSOR R
• Type of Device: ELECTROCARDIOGRAPHIC ELECTRODE, SINGLE-USE, PRODUCT CODE: DRX
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dk 2750 ; DA 2750
• MDR Report Key: 9186656
• MDR Text Key: 166157659
• Report Number: 1220828-2019-00011
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: R-00-S/25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/11/2019
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention