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

Model Number H1820

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There was no report of any patient harm as the device issue was found before use.Should additional information become available, a follow-up report will be submitted.

Event Description

It was reported that the tube detached from connector at the bifurcation point (joint connector) prior to use.A new device was used.

Manufacturer Narrative

Additional information received: lot number 106891 and expiration were provided.Correction due to device manufacture date not submitted on mdr manufacturer report number 9680866-2015-00074.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

Additional information: pending investigation was completed.The root cause for the disconnection was due to the lack of glue.Corrective actions have been defined to include re-training and establishing additional assembly time for product along the shift.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Manufacturer Narrative

Additional information was received on (b)(6) 2015.Returned product was received at the manufacturing site.A quality investigation was performed (b)(6) 2015.A used sample was returned to assist with the investigation.A visual examination was conducted and it was confirmed that one of the lariat tubes was disconnected from hose adapter.Product does not meet requirements of product specification that indicates that both tubes should be connected to hose adapter.This warrants further action and non-conformance will be opened.The compliant will remain open until completion of the non- conformance investigation.

• Brand Name: ADULT NASAL CANNULA WITH 7 FT. STAR LUMEN TUBI
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon secc. 4; lote 7, parque ind. del norte; reynosa, tams. 88736 ; MX 88736
• Manufacturer (Section G): CONVATEC; 211 american ave; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4996500
• MDR Text Key: 23323686
• Report Number: 9680866-2015-00074
• 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: Followup
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Model Number: H1820
• Device Lot Number: 106891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2014
• 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