FDA Adverse Event
Malfunction
Summary report: N
CYCLESURE BIOLOGICAL INDICATOR
MDR report key: 1060204
·
Received June 12, 2008
Report
- Report Number
- 2084725-2008-00264
- Event Type
- Malfunction
- Date Received
- June 12, 2008
- Date of Event
- May 11, 2008
- Report Date
- May 14, 2008
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- FRC
- PMA / PMN Number
- K994055
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE CODE: OTHER, SUSPECTED POSITIVE BI. CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE SERVICE ENGINEER WENT TO THE FACILITY AND FOUND THAT THE INJECTION PRESSURE AND THE "CYCLE PRESSURE" SHOWED NO PROBLEM. THE UNIT WORKED TO SPECIFICATIONS.
Description of Event or Problem · 1
THE AFFILIATE REPORTED A CUSTOMER WITH SUSPECTED POSITIVE BI. THE CUSTOMER REPORTED THAT NONE OF THE LOAD WAS RECALLED. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING POTENTIAL PATIENT INJURY. THE CUSTOMER REPORTED THAT THE LOAD WENT IN AS "USUAL". THE FIELD ENGINEER WENT TO THE FACILITY TO ASSESS THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYCLESURE BIOLOGICAL INDICATOR | NONE | FRC | ADVANCED STERILIZATION PRODUCTS | NA | 00981Z |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | CATALOG #10101| STERRAD 100S STERILIZATION SYSTEM |