MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for MCKESSON BRANDS 16-6423 manufactured by Shanghai Jianzhong Medical Packaging Co, Ltd.
[181729965]
Customer reported that their self seal sterilization pouches caught fire in their ritter m7 speedclave autoclave (serial # (b)(4)). Upon opening the machine she noticed that the bags were burning. She then put the autoclave on a cart and took it outside. The autoclave was reported to be 10 years old. Mckesson contacted the manufacturer of the autoclave to bring this to their attention as well. They indicated that the unit was built and shipped in 2003 (17 years ago). They indicated that there is potential for the operator to turn the unit on without water in the chamber, which would result in the chamber getting very hot. There is also the potential for a valve or gasket to not seal completely and allow the water that was initially in the chamber to escape and allow the chamber to get very hot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451040-2020-00002 |
| MDR Report Key | 9779313 |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-19 |
| Date Facility Aware | 2020-02-18 |
| Report Date | 2020-03-03 |
| Date Reported to FDA | 2020-03-03 |
| Date Reported to Mfgr | 2020-03-03 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | MCKESSON BRANDS |
| Generic Name | POUCH, SELF SEAL ECON 3.5X9 |
| Product Code | FRG |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-02-28 |
| Catalog Number | 16-6423 |
| Lot Number | CJZI11-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHANGHAI JIANZHONG MEDICAL PACKAGING CO, LTD |
| Manufacturer Address | BLDG.16 789# PUXING ROAD MINHANG DISTRICT SHANGHAI, SHANGHAI 201114 CH 201114 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-03 |