FDA Adverse Event
Malfunction
Summary report: N
DEROYAL INSUFFLATION TUBING WITH FILTER
MDR report key: 1932131
·
Received December 1, 2010
Report
- Report Number
- 3004605321-2010-00001
- Event Type
- Malfunction
- Date Received
- December 1, 2010
- Date of Event
- March 11, 2010
- Report Date
- March 30, 2010
- Manufacturer
- DEROYAL INDUSTRIES, INC.
- Product Code
- HIF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S DEVICE INVESTIGATION REVEALED THE PLASTICIZER IN THE TUBING MIGRATED AND SOFTENED THE FILTER HOUSING MATERIAL CAUSING AN OCCLUSION. HEAT WAS FOUND TO AGGRAVATE THE ACTION. THE FILTER HOUSING MATERIAL WAS SUBSEQUENTLY CHANGED TO POLYCARBONATE WHICH IS A STRONGER, HIGHER IMPACT AND MORE CHEMICALLY RESISTANT MATERIAL ALSO LESS AFFECTED BY HIGHER TEMPERATURES. THIS ACTION HAS ELIMINATED THE OCCLUSION ISSUES AS REPORTED BY THE FACILITY. THE CUSTOMER HAS ALSO ADVISED THERE WAS NO INJURY OR ILLNESS ASSOCIATED WITH THIS OCCURRENCE.
Description of Event or Problem · 1
THE HI-FLOW INSUFFLATION TUBING WAS PRE-STERILIZED IN THE LAPAROSCOPY PACK. THE FLOW WOULD NOT WORK THROUGH THE TUBE. A DIFFERENT TUBING WAS USED AND SURGERY CONTINUED WITH NO ILL EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEROYAL INSUFFLATION TUBING WITH FILTER | INSUFFLATION TUBING AND FILTER | HIF | DEROYAL INDUSTRIES, INC. | 002258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |