MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN BRITEPRO SOLO SINGLE-USE FIBRE OPTIC HANDLE AND BLADE MAC 4; LARYNGOSCOPE HANDLE SINGLE USE

Catalog Number 040-334U

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/24/2021

Event Type  malfunction  

Event Description

Upon intubation the plastic has broken off at the hub where the handle meets the blade.No harm was caused to the patient, the plastic was retrieved.

• Brand Name: BRITEPRO SOLO SINGLE-USE FIBRE OPTIC HANDLE AND BLADE MAC 4
• Type of Device: LARYNGOSCOPE HANDLE SINGLE USE
• 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 MEDICLA DONGGUAN; 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: 11391594
• MDR Text Key: 234500756
• Report Number: 3006061749-2021-00004
• 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: 03/01/2021

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 Catalogue Number: 040-334U
• Device Lot Number: 200501631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• 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
• Patient Weight: 70