MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2007-01-10 for FIRST BREATH ADULT VENTURI OXYGEN MASK * 002610 manufactured by Unomedical, Inc..
[15003648]
In 2006 unomedical inc. Was informed about a decision from smiths medical to classify as mdr a complaint received from foriegn country. In 2006 smiths medical usa was notified that one diluter was found to be occluded at the time of use. Deluter was immediately replaced an no adverse event to the patient occurred.
Patient Sequence No: 1, Text Type: D, B5
[15130198]
One (1) yellow diluter (28%) and one (1) white diluter (13%) returned were visually examined and the quality problem was confirmed as valid. Diluter had a thin membrane of the same plastic material covering the orifice of diluter. However, when the diluter was connected to air source at 4 lpm and 6 lpm, the plastic membrane was completely removed and immediately the occlusion disappeared. A review of our customer complaint files confirmed this to be an insolated quality problem. Stocks of oxygen diluters have been re-inspected and problems of this nature have not been found. We have concluded based on the investigation above that this was an isolated quality problem. The possible root cause was determined as an inadequate inspection. To prevent recurrence of quality problem reported above, unomedical has implemented as part of quality control plan a 100% physical inspection consisting of a manual insertion of appropriately- sized rods through the hole of all diluters. Lot# 05-48 reported was manufactured prior to this 100% inspection. Work instructions have been issued to instruct operators in how perform the inspection. Even though there was not an adverse event to the patient, unomedical has made the decision to voluntary submit an mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680866-2007-00001 |
| MDR Report Key | 809118 |
| Report Source | 01 |
| Date Received | 2007-01-10 |
| Date of Report | 2006-12-21 |
| Date of Event | 2006-11-21 |
| Date Mfgr Received | 2006-12-21 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2007-01-29 |
| 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 | 0 |
| Manufacturer Contact | EFAIN CARRERO OFFICAL COORESP |
| Manufacturer Street | 5701-I ST WARE RD. |
| Manufacturer City | MCALLEN TEXAS * * |
| Manufacturer Country | US |
| Manufacturer Postal | * |
| Manufacturer Phone | 9565838472 |
| Manufacturer G1 | UNOMEDICAL S.A. DE C.V. |
| Manufacturer Street | PARQUE INDUSTRIAL DEL NORTE SECCION 4, LOTE NO. 7 |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIRST BREATH ADULT VENTURI OXYGEN MASK |
| Generic Name | 73 BYG MASK, VENTURI |
| Product Code | BYF |
| Date Received | 2007-01-10 |
| Model Number | * |
| Catalog Number | 002610 |
| Lot Number | 05-48/UNK |
| ID Number | * |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 796615 |
| Manufacturer | UNOMEDICAL, INC. |
| Manufacturer Address | 5701-I ST. WARE RD. MCALLEN TX 78503 US |
| Baseline Brand Name | VENTURI MASK |
| Baseline Generic Name | VENTURI MASK KIT, ALL DILUTERS |
| Baseline Model No | 002610 |
| Baseline Catalog No | 002610 |
| Baseline Device Family | OXYGEN MASK |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K780626 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-01-10 |