MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-04 for STEAM TAPE manufactured by Steris Biological Operations.
[97498092]
No report of procedure delay or cancellation. The instruments present during the time of the reported event were reprocessed before use. The user facility obtained the verify steam tape subject of the reported event from a steris distributor, owens & minor. Following the reported event, user facility personnel contacted owens & minor to describe the event that took place. The verify steam tape instructions for use states (pg. 1), "expose pack to the steam sterilization process. Following processing, remove the pack and examine the tape. The white indicator bars will be brown to black in color if exposed to steam sterilization conditions. " retain testing was performed on the lot number subject of the reported event; no issues were noted. The dhr for the subject lot was reviewed and no abnormalities were found. The user facility is returning on hand inventory for the lot subject of the reported event to steris. Steris will offer in-service training on the proper use of the verify steam tape to the user facility. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[97498093]
The user facility reported via medwatch report #(b)(4) that their verify steam tape did not change colors following a completed cycle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004080920-2018-00001 |
| MDR Report Key | 7166028 |
| Date Received | 2018-01-04 |
| Date of Report | 2018-01-04 |
| Date Mfgr Received | 2017-12-05 |
| Date Added to Maude | 2018-01-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | STERIS BIOLOGICAL OPERATIONS |
| Manufacturer Street | 9325 PINECONE DR. |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STEAM TAPE |
| Generic Name | STEAM TAPE GENERAL PURPOSE STEAM INDICATOR TAPE |
| Product Code | JOJ |
| Date Received | 2018-01-04 |
| Lot Number | 709401 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS BIOLOGICAL OPERATIONS |
| Manufacturer Address | 9325 PINECONE DR MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-04 |