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

Model Number 106-E

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 09/29/2014

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.Per the information provided, there was no report of harm to the patient.A review of the batch record was performed which did not identify any discrepancies or abnormalities during manufacture.However product lot involved in the current complaint was manufactured before implementation of actions documented a previous corrective/preventive action to address the improper solvent bond issue identified as the probable cause of disconnection.All products manufactured after july 04, 2014 have been properly assembled and verified to prevent the reported disconnection.It was recommended to review the risk assessment in order to update the probability of recurrence of this type of failure and determine if further actions are required.A request for additional information has been made, however 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 the connection between the tubing and the mask was quite loose.

Manufacturer Narrative

Corrected info for the date received by mfr.The mfr report number previously submitted on october 17, 2014 is also being corrected to mfr report number 9680866-2014-00035.No additional patient/event details have been provided to date.Should add'l info become available a follow-up report will be submitted.

Manufacturer Narrative

Additional information was received november 04, 2014.Investigation on capa was reopened to update the information about eight complaints of the same disconnection received after the first investigation was performed.There is evidence of solvent application around external surface of tube adapter, but it is difficult to determine if the same amount of solvent was applied around the internal surface that makes friction with the mask connector.Batch records review (brr) did not identify any discrepancies or abnormalities during manufacture.The product lots for the eight complaints were manufactured before implementation of actions identified in the first investigation and no other causes were identified in the evaluation of returned samples.Therefore the possible causes and actions identified in the first investigation apply for those additional complaints that involve products manufactured before july 04, 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. ; MX
• Manufacturer (Section G): UNOMEDICAL S.A. DE C.V.; av. industrial falcon secc. 4; lote 7, parque ind. del norte; reynosa, tams. ; MX
• Manufacturer Contact: matthew walenciak, director ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 8570266
• MDR Text Key: 143835912
• Report Number: 9680866-2014-00035
• Device Sequence Number: 1
• Product Code: KGB
• 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: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• 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: 106-E
• Device Catalogue Number: 106-E
• Device Lot Number: 104701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2014
• 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: Unknown
• Patient Sequence Number: 1