MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN LTD BRITEBLADE PRO SINGLE USE FIBRE OPTIC CENTRELINE MILLER 00; LARYNGOSCOPE BLADE, SINGLE USE

Catalog Number 040-00-1800U

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

After initial evaluation during a weekly complaints review meeting on 09-sep-2020, it was decided to seek further information on the incident.We attempted to contact the user and sales representative on 3 occasions to establish further information but none of these attempts were answered.The incident was reviewed again in the weekly review meeting with the assistance and guidance of product managers/specialists, technical and regulatory departments on 16-sep-2020 and without any further assistance/communication the incident was recorded as low risk and not reportable based on the fact the per form stated the physician did not allege the device caused the event and that there was no adverse effect to the patient.The form is being submitted under the guidance and recommendation of flexicare inc managers as a method of recording the incident for future reference purposes.

Event Description

A small cut was noticed in the baby's throat after intubation.

• Brand Name: BRITEBLADE PRO SINGLE USE FIBRE OPTIC CENTRELINE MILLER 00
• Type of Device: LARYNGOSCOPE BLADE, SINGLE USE
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN LTD; no.b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN LTD; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer Contact: darryl ridge ; cynon valley business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 10785846
• MDR Text Key: 216415556
• Report Number: 3006061749-2020-00007
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/30/2020

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: 03/31/2024
• Device Catalogue Number: 040-00-1800U
• Device Lot Number: 190500084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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
• Patient Outcome(s): Other