MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OXYGEN MASKS, ELONGATED (UNDER CHIN), ADULT; MASK, OXYGEN, NON-REBREATHING

Model Number 108-E

Device Problem Disconnection (1171)

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

Event Date 09/01/2015

Event Type  malfunction  

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 patient/event details have been requested; however, no further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported the tubing disconnected from the oxygen mask immediately upon use.The mask was removed and replaced with a new mask.No patient complications were reported as a result of this event.

Manufacturer Narrative

Correction clarify event details: the mask was removed and replaced with a new mask from the "same lot".Additional information: a batch review was conducted and no discrepancies were found.There is no previous investigation available to leverage.Samples from current production lot number 104-e were checked and tested.All samples met retention requirement of 10 pounds between tube adapter and mask connector.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required at this time.A returned sample was expected, but not received.The investigation will be re-opened upon receipt of the complaint sample.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 MASKS, ELONGATED (UNDER CHIN), ADULT
• 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 (Section G): CONVTEC; 211 american ave; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5150252
• MDR Text Key: 28305441
• Report Number: 9680866-2015-00091
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/24/2015

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: 02/01/2020
• Device Model Number: 108-E
• Device Lot Number: 109186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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