FDA Adverse Event
Malfunction
Summary report: N
STERRAD TYVEK POUCH
MDR report key: 1395148
·
Received March 12, 2009
Report
- Report Number
- 2084725-2009-00171
- Event Type
- Malfunction
- Date Received
- March 12, 2009
- Date of Event
- February 3, 2009
- Report Date
- February 13, 2009
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- KCT
- PMA / PMN Number
- K951295
- Removal / Correction Number
- Z-0844-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DAMAGED DEVICE.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED A LIGHT CABLE WAS STUCK TO THE TYVEK POUCH AFTER IT WAS PROCESSED IN THE STERRAD UNIT. THE CUSTOMER STATED THE OUTER COVERING OF THE CORD TORE OFF BECAUSE, IT WAS STUCK TO THE WALL OF THE POUCH WHEN THE POUCH WAS OPENED. THE CUSTOMER STATED THAT THE OTHER LIGHT CORDS WERE ALSO STUCK AND ATTEMPTED TO REMOVE THEM BY SOAKING. THE CUSTOMER STATED THAT ACCORDING TO THE MANUFACTURER, THE LIGHT CORD WAS NOT SUPPOSED TO BE PROCESSED IN THE TYVEK POUCH. THE CUSTOMER STATED THAT THE FORMER HEALTHCARE WORKER DID NOT FOLLOW INSTRUCTIONS. THERE WERE NO PTS OR INJURIES INVOLVED FROM THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERRAD TYVEK POUCH | UNKNOWN TYVEK POUCH | KCT | ADVANCED STERILIZATION PRODUCTS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | STRYKER LIGHT CORD: UNKNOWN MODEL, SN#| STERRAD NX STERILIZER |