MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2016-02-25 for VENTURI MASK KIT ADULT 120A-MM manufactured by Unomedical S.a De C.v..
[39036717]
Expiration date- 04/2020. Manuf. Date- 04/2015. Based on the available information, this event is deemed to be a reportable malfunction. A return sample was not available for evaluation, therefore could not confirm a discrepancy in the product. After a detailed review of batch records for the product and lot, no discrepancies (including non-conformances/deviations) were found. The evaluation of stock samples indicated that adjustable diluter performed as intended and meets the specification requirements. There is not enough information to conclude the product did not meet specification or perform as intended. Product monitoring reviews will monitor for product trends if this issue were to reoccur. No further actions are required and the complaint will be closed. Further patient/event information was requested although no additional details have been provided to date. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39036718]
It was reported that the "oxygen flow does not normalize as indicated. At the smallest inspired oxygen fraction, the flow is higher and the lower flow fraction increases. " no patient harm resulted due to the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[40977206]
Additionally, mfr report# 9680866-2016-00065 and mfr report# 9680866-2016-00066 which were submitted on 02/25/2016, are for the same patient and these complaint records are associated with each other. No additional details have been provided to date. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680866-2016-00066 |
| MDR Report Key | 5460660 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-02-25 |
| Date of Report | 2016-02-01 |
| Date of Event | 2016-01-13 |
| Date Mfgr Received | 2016-03-10 |
| Date Added to Maude | 2016-02-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTURI MASK KIT ADULT |
| Generic Name | MASK, OXYGEN, LOW CONCENTRATION |
| Product Code | BYF |
| Date Received | 2016-02-25 |
| Model Number | 120A-MM |
| Lot Number | 110550 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL S.A DE C.V. |
| Manufacturer Address | AV.:INDUSTRIAL FALCON LOTE 7 PARQUE IND, DEL NORTE REYNOSA, TAMAULIPAS 88736 MX 88736 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-25 |