MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OXYGEN & AEROSOL THERAPY; MASK, OXYGEN, NON-REBREATHING

Model Number 106-E

Device Problem Connection Problem (2900)

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

Event Date 08/19/2014

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.There are three (3) cases associated with this product; therefore a separate fda form 3500a has been generated to address the other two (2) cases.The device was used on a patient however there was no report of harm to the patient.It was reported that the patients' height and weight would be difficult for to obtain.Furthermore, they don't exactly know how long the mask was being used on patients, but it was a very short time as they have only been using the masks for a few weeks.An initial quality evaluation was performed on 06/24/2014.Three samples were received 07/07/2014.The investigation performed by the quality department revealed that the cause of disconnection was a poor solvent application in the assembly of tube adapter and mask connector.The possible root causes identified were: (1) inadequate solvent dispenser and (2) inadequate work instructions.Actions to address this quality issue have been identified and have been documented into a capa created for this quality issue.Actions include improvements in the assembly work instructions and controls over fixtures like solvent dispenser used in the manufacturing process.The following additional corrective and preventive actions have been identified: review work instruction to clarify and distinguish the three types of approved solvent dispensers; review process instruction to specify and clarify the type of approved dispenser for each step in the assembly process; review process instructions for other products to specify and clarify the type of approved dispenser for each step in the assembly process.The following additional corrective and preventive actions have been identified: all solvent dispenser drawings and drawings of fixtures used in the assembly processes are stored in a validated document control system; implement maintenance procedure for solvent dispensers; measure and evaluate each production fixture or tool against approved drawings; implement a procedure for periodical review of solvent dispensers; retraining employees on new procedures; re-validate extrusion process for oxygen tubes, considering all internal and external features which could impact the process and the product.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.

Event Description

It was reported an issue with the tubing becoming disconnected from the port on mask spontaneously for the product.It was reported the end users mask was taped at the spot where the hose connects to the post on mask as well as where the bag attaches to the mask.

Manufacturer Narrative

The date received by convatec is being corrected to reflect the date the three samples were received by the manufacturing site for investigation 07/07/2014.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: OXYGEN & AEROSOL THERAPY
• 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. 88736 ; MX 88736
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 8569621
• MDR Text Key: 145002316
• Report Number: 9680866-2014-00025
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106-E
• Device Catalogue Number: 106-E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2014
• 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