MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-25 for ONE TRAY manufactured by Innovative Sterilization Technologies Llc.
[75941270]
This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10
[75941271]
We have recently obtained one tray to use in our immediate use steam sterilizer. This is used to get quicker access to instruments needed with the preface that this "one tray" would provide the rapid sterilization to terminally sterilize with in the regulatory guidelines in a pre-vacuum cycle in 4 minutes. This is completed by a filtered vent and the thermodynamic behavior of steam. These filters are labeled as hydrophobic- meaning water is to bead on them and not go through them. These filters are a one time use and are changed with each process. It was our experience that the filters had not been hydrophobic. There was apparent water at the bottom of the tray. Manufacturer response for sealed sterilization container, one tray (per site reporter): the representative came to the o. R. And watch a cycle run. Everything that staff did was appropriate and to the manufacturer's recommendations. They had suggested that this was possible due to our water quality. The same testing was completed with sterile water and it resulted in the same defect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6590316 |
| MDR Report Key | 6590316 |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-08 |
| Date of Event | 2017-04-26 |
| Report Date | 2017-05-05 |
| Date Reported to FDA | 2017-05-05 |
| Date Reported to Mfgr | 2017-05-05 |
| Date Added to Maude | 2017-05-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONE TRAY |
| Generic Name | STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES |
| Product Code | KCT |
| Date Received | 2017-05-25 |
| Lot Number | 85280, 84997, 85289, 85894 |
| ID Number | KIT NUMBER: K02170429 |
| Device Availability | N |
| Device Age | 14 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNOVATIVE STERILIZATION TECHNOLOGIES LLC |
| Manufacturer Address | 7625 PARAGON RD. STE. A DAYTON OH 45459 US 45459 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-25 |