MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-05 for VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE manufactured by Steris Biological Operations.
[131314912]
A steris account manager went onsite and spoke with the user facility personnel regarding the reported event. Facility personnel stated that an employee went to activate the bi and found that the foil seal that retains the bi media was damaged and that no media remained. Due to the damage sustained to the foil seal prior to use, the liquid media inside the bi was removed during the vacuum pull phase of the sterilization cycle in the sterrad unit. The process challenge device instructions for use (pg. 1) states, "instructions for use: before use, examine the pcd to ensure that the foil and seal are intact. Examine the integrator through the plastic, to ensure the pcd has not been used previously. " retain testing was performed on the lot number subject of the reported event; no issues were noted, the foil seal was found to be intact. The dhr was reviewed and no abnormalities were found. While onsite, the steris account manager was able to perform in-service training on proper use of the biological indicator specifically inspecting the foil seal before use. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[131314913]
The user facility reported a dry biological indicator (bi) following a processing cycle. The instruments had to be reprocessed prior to use causing a procedure delay. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004080920-2018-00003 |
| MDR Report Key | 8134626 |
| Date Received | 2018-12-05 |
| Date of Report | 2018-12-05 |
| Date of Event | 2018-11-05 |
| Date Mfgr Received | 2018-11-05 |
| Date Added to Maude | 2018-12-05 |
| 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 | VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE |
| Generic Name | VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE |
| Product Code | OWP |
| Date Received | 2018-12-05 |
| Lot Number | 20190501F |
| Device Availability | Y |
| 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 | 2018-12-05 |