ENDOTRACHEAL TUBE INTRODUCER UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-04-08 for ENDOTRACHEAL TUBE INTRODUCER UNK manufactured by Meditec Devices.

Event Text Entries

[1585941] Anesthesia inserted et tube in operating room. Three and half hours later, the pt coughed up a small blue plastic piece, thought to be from this device. Appears to have broken off at the curved tip. Approximately one inch broke off. Tip retained, stylet and original package not retained. No electrophysiology procedure performed. Original intended procedure was intubation for cervical spine exploration and hardware removal.
Patient Sequence No: 1, Text Type: D, B5

[8695007] .
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2183650-2010-00003
• MDR Report Key: 1817046
• Report Source: 99
• Date Received: 2010-04-08
• Date of Report: 2010-04-07
• Date of Event: 2010-02-08
• Date Facility Aware: 2010-03-24
• Report Date: 2010-04-07
• Date Reported to Mfgr: 2010-04-07
• Date Added to Maude: 2011-05-04
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ENDOTRACHEAL TUBE INTRODUCER
• Generic Name: ENDOTRACHEAL TUBE INTRODUCER
• Product Code: BWB
• Date Received: 2010-04-08
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: NA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDITEC DEVICES
• Manufacturer Address: VASAI (E), THANE IN

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-04-08