MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-10-08 for VALSURE NEUTRAL DETERGENT manufactured by Steris Corporation.
[27830831]
The user facility used valsure neutral detergent to soak their instruments prior to use in patient procedures. After the procedures were completed, two patients reported symptoms of toxic anterior segment syndrome (tass). The user contacted steris to inquire about valsure as a part of their investigation for the reported event as this was recently added to their process for cleaning. The user facility declined to provide additional information regarding the reported injury or current status of the patients subject of the reported event. A steris account manager spoke with the user facility regarding the use of valsure neutral detergent and identified the user facility was not following the instructions for use as indicated on the product's label. The cleaning solution was diluted to 1/8 oz per 1 gallon of water which is below the recommended dosing for the cleaning solution. The instructions for use for valsure neutral detergent state, "dilute at 1-3 ounces per gallon, depending on water quality and soil load. " after reviewing the instructions for use, the user facility acknowledged that they do not believe that valsure neutral detergent contributed to the reported injury. Steris has performed in-service training with user facility about the proper cleaning techniques and dosages for valsure neutral detergent to ensure proper cleaning of their surgical instruments.
Patient Sequence No: 1, Text Type: N, H10
[27830832]
The user facility contacted steris to inquire about the proper cleaning procedure for cleaning instruments with valsure neutral detergent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937531-2015-00010 |
| MDR Report Key | 5135572 |
| Report Source | USER FACILITY |
| Date Received | 2015-10-08 |
| Date of Report | 2015-10-07 |
| Date of Event | 2015-09-10 |
| Date Mfgr Received | 2015-09-10 |
| Date Added to Maude | 2015-10-08 |
| 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 | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CORPORATION |
| Manufacturer Street | 7501 PAGE AVENUE |
| Manufacturer City | ST. LOUIS MO 63133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALSURE NEUTRAL DETERGENT |
| Generic Name | DETERGENT |
| Product Code | FLG |
| Date Received | 2015-10-08 |
| Lot Number | 274714 14A5. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 7501 PAGE AVENUE ST. LOUIS MO 63133 US 63133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-08 |