MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. ADULT NASAL CANNULA WITH 7 FT. STAR LUMEN TUBING; CANNULA, NASAL, OXYGEN

Model Number H1820

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2015

Event Type  malfunction  

Event Description

It was reported the 'inside' lumen of the nasal cannula supply tubing seemed to be deformed or flattened.The malfunction was noted prior to use.A new nasal cannula tubing set was used.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: ADULT NASAL CANNULA WITH 7 FT. STAR LUMEN TUBING
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon; lote 7, parque ind. del norte; reynosa, tamaulipas 8873 6; MX 88736
• Manufacturer Contact: matthew walenciak, int assoc dir ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4491496
• MDR Text Key: 5332830
• Report Number: 9680866-2015-00014
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: H1820
• Device Lot Number: 102888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1