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

Catalog Number 040-713U

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation into the process and component parts used to assemble the product identified that a loose fitting could result when parts close to the minimum tolerance were used in conjunction with parts near maximum tolerance.Ie there could be a "tolerance stack".Production placed on hold.Drawing update to tighten tolerances.New supply of parts to updated tolerances.Validation & testing prior to recommencement of production.

Event Description

Clinician engaged the blade onto a disposable handle, then, when she went to intubate patient, blade broke while inside the patient's mouth.Doctor secured all the pieces immediately.

• Brand Name: BRITEBLADE PRO SINGLE-USE FIBER OPTIC MAC 3
• Type of Device: SINGLE-USE LARYNGOSCOPE BLADE
• 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: richard downs ; cynon valley business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 8464352
• MDR Text Key: 140318252
• Report Number: 3006061749-2019-00009
• 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: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 040-713U
• Device Lot Number: 181100001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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): Required Intervention