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

Model Number 3104-E

Device Problem Connection Problem (2900)

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

Event Date 09/18/2014

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.There was no reported harm to the patient as the device did not reach the patient.A quality evaluation was performed on october 16th, 2014.Batch records review did not identify any discrepancies or abnormalities during manufacture.However, product lot involved in the current complaint was manufactured before implementation of actions documented in a corrective action preventative action, to address the improper solvent bond issue identified as the probable cause of disconnection.Some actions in the capa are still in process; however all products manufactured after july 04, 2014 have been properly assembled (glued), and verified to prevent the reported disconnection.Note: issue occurred on (2) separate cases.A separate 3500a form has been completed for the other (1) case for a different lot number, same product code.No additional information has been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on october 17, 2014.(b)(4).

Event Description

It was reported that a respiratory therapist checked the oxygen tube to mask device prior to use on a patient.It is reported that the tubing became disconnected when light tugging was applied with packaging unopened.Http://emdr.Fda.Gov/emdr/formmedwatch2/3500a/b.Jsf#.

• Brand Name: OXYGEN AND AEROSOL THERAPY
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon ; lote 7, parque ind. del norte; reynosa, tamaulipas 88736 ; MX 88736
• Manufacturer Contact: matthew walenciak, director ; 211 amaerican ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5748590
• MDR Text Key: 48211369
• Report Number: 9680866-2014-00034
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• 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: 3104-E
• Device Catalogue Number: 3104-E
• Device Lot Number: 104901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2014
• 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: Initial
• Patient Sequence Number: 1