MAUDE Adverse Event Report: UNOMEDICAL SDN BHD REINFORCED ENDOTRACHEAL TUBES - WITHOUT MURPHY; STYLET, TRACHEAL TUBE

Model Number MM61224165

Device Problem Occlusion Within Device (1423)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/28/2015

Event Type  Injury  

Event Description

It was reported that during intubation, the endotracheal tube lumen became occluded.Due to an 'impossibility of ventilation', the patient required extubation and, subsequently, reintubation.It was further reported the patient experienced oxygen desaturation during the process.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.The initial reporter was unable to provide the lot number of the device involved but, provided three potential lot numbers.Additional information has been requested from the initial reporter, including clarification on the correct lot number, as well as, other patient and event details.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.

• Brand Name: REINFORCED ENDOTRACHEAL TUBES - WITHOUT MURPHY
• Type of Device: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): UNOMEDICAL SDN BHD; bakar arang industrial estate; sungai petani, kedah 0800 0; MY 08000
• Manufacturer Contact: matthew walenciak, int. dir. ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4663461
• MDR Text Key: 20788086
• Report Number: 9611710-2015-00054
• Device Sequence Number: 1
• Product Code: BSR
• Combination Product (y/n): N
• Reporter Country Code: TS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MM61224165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other