MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for COMPLY? 1233LF manufactured by 3m Company.
[139550470]
Reported that the bowie dick comply test failed 4 times in 3 different sterilizers. All tests came from the same box with the same lot #. After each failure, each sterilizer was inspected/examined by the manufacturer's service technician. The technician found nothing wrong with any of the 3 sterilizers and recommended that the bowie dick test from a different lot # be run in all 3 autoclaves. This was done and all three passed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8443242 |
| MDR Report Key | 8443242 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-03-01 |
| Report Date | 2019-03-08 |
| Date Reported to FDA | 2019-03-08 |
| Date Reported to Mfgr | 2019-03-22 |
| Date Added to Maude | 2019-03-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPLY? |
| Generic Name | INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS |
| Product Code | JOJ |
| Date Received | 2019-03-22 |
| Model Number | 1233LF |
| Catalog Number | 1233LF |
| Lot Number | 202101CH |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Manufacturer Address | 3M CENTER, 2510 CONWAY AVE. BLDG. 275-5W-06 SAINT PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-22 |