MAUDE Adverse Event Report: MEDICAL DEVICES (PVT) LTD LARYNGOSCOPE BLADE, MAC2, DISPOSABLE, GREEN; DISPOSABLE LARYNGOSCOPE BLADE

Catalog Number 301-B3020

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2014

Event Type  malfunction  

Event Description

While anesthesiologist was trying to intubate pt the plastic tube light on the blade broke and plastic was in pts back area of mouth.Anesthesiologist removed plastic from pt mouth and then proceeded to go back in and intubate pt.

• Brand Name: LARYNGOSCOPE BLADE, MAC2, DISPOSABLE, GREEN
• Type of Device: DISPOSABLE LARYNGOSCOPE BLADE
• Manufacturer (Section D): MEDICAL DEVICES (PVT) LTD; ugoki, sialkot ; PK
• MDR Report Key: 3670463
• MDR Text Key: 15932775
• Report Number: 1036445-2014-00002
• Device Sequence Number: 1
• Product Code: EQN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/26/2014,02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 301-B3020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2014
• Distributor Facility Aware Date: 02/05/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1