FDA Adverse Event
Malfunction
Summary report: N
LOGICAL DOUBLE KIT
MDR report key: 1841310
·
Received September 16, 2010
Report
- Report Number
- 2183502-2010-00393
- Event Type
- Malfunction
- Date Received
- September 16, 2010
- Date of Event
- August 10, 2010
- Report Date
- September 8, 2010
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD.
- Product Code
- DRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. UPON EXAMINATION, IT WAS CONFIRMED THAT THE TUBING HAD DISCONNECTED AT A SECTION WHERE IT HAD BEEN SOLVENT BONDED. THE BONDED AREA WAS VISUALLY EXAMINED, SOLVENT WAS PRESENT AT THE BONDED CONNECTIONS AND THE BONDING PROCESS APPEARED ACCEPTABLY PERFORMED. CRITICAL DIMENSIONS WERE MEASURED AND WERE FOUND TO CONFORM TO THE MANUFACTURER'S SPECIFICATIONS; NO ABNORMALITIES OR DEFECTS WERE FOUND. OUR EVALUATION WAS UNABLE TO DETERMINE ROOT CAUSE AND WE WERE UNABLE TO DETERMINE HOW OR WHEN THE DEVICE BECAME DISCONNECTED.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE DEVICE TUBING SEPARATED PRIOR TO USE. THERE WAS NO REPORTED PATIENT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOGICAL DOUBLE KIT | PRESSURE MONITORING SET | DRS | SMITHS MEDICAL INTERNATIONAL LTD. | NA | 1809392 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |