MAUDE Adverse Event Report: FLEXICARE, INC. BRITEBLADE PRO; LARYNGOSCOPE, RIGID

Catalog Number 040-713U

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 02/28/2019

Event Type  malfunction  

Event Description

A crna opened a briteblade pro 3 laryngoscope blade from its original packaging to find that several small/ loose parts were contained in the packaging.This product was immediately removed/ sequestered prior to patient contact.The crna report of the affected briteblade pro blade resulted in our supply liaisons removing all briteblade's from our operating room supply areas - upon product removal, we have identified an additional affected unit from a different lot #.

• Brand Name: BRITEBLADE PRO
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE, INC.; 15281 barranca parkway; unit d; irvine CA 92618
• MDR Report Key: 8431606
• MDR Text Key: 139168461
• Report Number: 8431606
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 040-713U
• Device Lot Number: 180700030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA