MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN BRITEBLADE PRO SINGLE-USE FIBRE OPTIC MAC 3; SINGLE USE LARYNGOSCOPE BLADE

Catalog Number 040-713U

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Skin Tears (2516)

Event Type  malfunction  

Manufacturer Narrative

The report has been received as a 3rd party event recorded by dr.(b)(6).From the photographs in the report received, the laryngoscope appears to have been inserted too far into the patients' mouth, whereby the hook has come in contact with the patients' lip and resulted in the abrasion.The conclusions from the limited amount of information received implies the incorrect size selection of laryngoscope blade.A search through the previous 5 years of complaint registers resulted in no other instances of this kind being reported.The report also ignores the fact the hook is incorporated as part of the design to prevent the blade touching the handle and potentially contaminating the handle.The report also omits the fact there are other devices which are of similar design on the market.

Event Description

After intubation the patient was discovered to have a small cut on his lip.Blood was noticed on the blade and handle.

• Brand Name: BRITEBLADE PRO SINGLE-USE FIBRE OPTIC MAC 3
• Type of Device: SINGLE USE LARYNGOSCOPE BLADE
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN; 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; 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: 11108248
• MDR Text Key: 262193027
• Report Number: 3006061749-2021-00001
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2021

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 Catalogue Number: 040-713U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 75 YR