MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. ADULT HIGH CONCENTRATION NON-REBREATHER, 7 FT; MASK, OXYGEN, NON-REBREATHING

Model Number 106MM

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

It was reported the tubing was found to come loose and fall off at the oxygen mask connector.

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.Additional information was requested.Should additional information become available, a follow-up report will be submitted.

Manufacturer Narrative

Additional information was received on march 10, 2015 providing clarification of the complaint details.Sections (date of event), (date of this report) (model #), (initial reporter address), (date received by manufacturer) and (device manufacture date) has been updated based on additional info received.A new complaint form was submitted for lot# 104106.(b)(4) is the (b)(6) internal code for unomedical code 106mm.The mask was used on a patient at the time the fault with tubing was found, several other masks from the same box were tried and a number of these also found to have tubing which came away from the mask very easily.The patient did not experience harm or an adverse event caused by the defect/malfunction although there was potential for severe harm or death.The product incident form states that the product was received on january 7th 2015 and sent to procurement on january 8th 2015.The tubing was directly connected to the mask.Additionally, the complainants response stated "we checked all of the hospital stock and found a number of masks in 2 different lot numbers - over 40 affected.We removed the following lots: 104798 and 104106 of the affected masks from the store cupboards in all departments." a follow-up is being conducted to confirm the number of devices and lots affected.A quality investigation was performed.A product sample was not available to assist with the investigation.Batch records of the product lot# 104798 were checked and it was found that the product was manufactured according to specification.The product was manufactured on june 12, 2014 according to work instructions.The product was statistically inspected and tested as per the implemented quality inspection procedures and all tested samples met the specification requirements.There are no nonconformities reported for product 106mm.However, a corrective and preventive action event was created to address the oxygen tube disconnection issues reported in the high concentration oxygen masks.Actions documented into the corrective and preventive action was implemented on july 30, 2014.Icc code# 106mm, lot# 104798 was manufactured before implementation of actions to address reported disconnection issues.Historical trend of brand name- product type "oxygen and aerosol therapy" from 10/28/2014 to 03/10/2015 indicates that: nineteen complaints have been created for connection issues.Six complaints have been created for icc code# 106mm.The investigation performed by the quality department at the manufacturing site indicated that current production samples are meeting the specification requirements.Reported quality issue was previously investigated and root causes addressed in the capa event on july 30, 2014.Product involved in the current complaint was manufactured before july 30, 2014; therefore reported disconnection could be related with the same causes already identified and addressed.No additional actions have been identified as result of this analysis.A returned sample was expected, but not received.The investigation will be re-opened upon receipt of the complaint sample.This issue will continue to be monitored per the convatec complaint handling process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on april 01, 2015.

Manufacturer Narrative

This supplemental report is being submitted as the results of the investigation indicated that the cause of disconnection was poor solvent application on the assembly of tube adaptor to mask connector.Maintenance records for extrusion and molding machines were examined during batch records review and no discrepancies were found.The possible root causes identified were: inadequate assembly work instructions; and inadequate solvent dispenser; inadequate assembly technique.A corrective action was initiated to address the manufacturing quality inconsistencies and additional training initiatives were implemented for the operators and has been closed.Therefore this complaint can be closed and no further actions are required.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on may 13, 2016.

• Brand Name: ADULT HIGH CONCENTRATION NON-REBREATHER, 7 FT
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon secc. 4; lote 7, parque ind. del norte; reynosa, tams. ; MX
• MDR Report Key: 4603106
• MDR Text Key: 5469643
• Report Number: 9680866-2015-00019
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,foreign,other,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: 106MM
• Device Lot Number: 104798
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2015
• Initial Date FDA Received: 03/10/2015
• Supplement Dates Manufacturer Received: 04/15/2016; 04/15/2016
• Supplement Dates FDA Received: 04/02/2015; 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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