MAUDE Adverse Event Report: UNOMEDICAL S.R.O. ICU/O2 & AEROSOL/CATHETER; CATHERTER, NASAL, OXYGEN

Model Number 19035182

Device Problems Electrical /Electronic Property Problem (1198); Sparking (2595); Flare or Flash (2942)

Patient Problem Burn(s) (1757)

Event Date 08/24/2011

Event Type  Injury  

Event Description

It is reported while patient was undergoing diathermy during use of the product, a spark was generated which became a flame.The flame progressed through delivery device to patient resulting in patient suffering minor burns into trachea and pharynx.The patient was sent to the hospital for further treatment, and was discharged and recovered completely.It is reported that the incident affected two (2) elderly patients.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.It is reported that both were outpatient procedures, but in different centers (they have two centers) by different surgeons.Both were excisions of in situ skin cancers near the nostril.In the other nostril, they had the catheter directing the oxygen flow.It is their routine procedure.When using the elctrocauther, there was a spark and a flame which had never happened before.An investigation performed on (b)(6) 2011 based on evaluation on two (2) unused samples (lot no(s) 399286 and 401737) in closed peel pack were received and tested.The samples provided were tested, including visual test, measurements against the drawing and we determined that it met our specified requirements.In conclusion, the investigation of this matter has been done previously and the results are available in a documented corrective action preventive action (capa) event.Note: this is the second instance where "patient had a burn of the trachea/pharynx".This case is related to patient identifier#: (b)(4) reported under manufacturer's report#: 3005778470-2014-00030.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.Note: this mdr is being reported as a result of a retrospective review of complaint records conducted by convatec for complaints received from may 01, 2011 - september 30, 2013.Reported to the fda on may 28, 2014.Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures.

• Brand Name: ICU/O2 & AEROSOL/CATHETER
• Type of Device: CATHERTER, NASAL, OXYGEN
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce 0710 1; LO 07101
• Manufacturer Contact: matthew walenciak, associate dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3879469
• MDR Text Key: 17928099
• Report Number: 3005778470-2014-00031
• Device Sequence Number: 1
• Product Code: BZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 19035182
• Device Catalogue Number: 19035182
• Device Lot Number: 399286
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2011
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2011
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention