FDA Adverse Event
Malfunction
Summary report: N
DISPOSABLE PRESSURE TRANSDUCER WITH 60" MONIT
MDR report key: 1052203
·
Received May 21, 2008
Report
- Report Number
- 1526863-2008-00020
- Event Type
- Malfunction
- Date Received
- May 21, 2008
- Date of Event
- March 20, 2008
- Report Date
- April 21, 2008
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- DRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SUBASSEMBLY IN QUESTION IS MANUFACTURED BY SMITHS MEDICAL. THE ASSEMBLY IS INCORPORATED INTO THE FINISHED PRODUCT (MX9504) BY SMITHS MEDICAL INTERNATIONAL IN ANOTHER COUNTRY. THE FINISHED PRODUCT IS FURTHER ASSEMBLED, PACKAGED AND STERILIZED BY SMITHS MEDICAL INTERNATIONAL. THE REPORTER INDICATED THAT THE SAMPLE WAS UNAVAILABLE FOR RETURN. SMITHS WAS UNABLE TO CONFIRM THE ISSUE OR DETERMINE A POSSIBLE CAUSE WITHOUT RETURNED PRODUCT EVAL. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.
Description of Event or Problem · 1
FOREIGN CLINIC REPORTED TO SMITHS MEDICAL INTERNATIONAL THAT THE CONNECTION WITH THE ARTERIAL CATHETER DETACHED FROM THE TUBING. THERE WAS NO PT INJURY OR TREATMENT REPORTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE PRESSURE TRANSDUCER WITH 60" MONIT | PRESSURE MONITORING SET | DRS | SMITHS MEDICAL ASD, INC. | NA | 1158324 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |