FDA Adverse Event
Malfunction
Summary report: N
LOGICAL 60" SINGLE LINE MONITORING KIT
MDR report key: 1032219
·
Received April 18, 2008
Report
- Report Number
- 9616567-2008-00032
- Event Type
- Malfunction
- Date Received
- April 18, 2008
- Date of Event
- March 14, 2008
- Report Date
- March 20, 2008
- Manufacturer
- SMITHS MEDICAL, ASD
- Product Code
- DRS
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER INDICATED THAT SAMPLES WERE AVAILABLE; HOWEVER, PRODUCT HAS NOT YET BEEN RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY WAS REVIEWED WITH NO RELATED ISSUES. SMITHS WAS UNABLE TO CONFIRM THE ISSUE OR DETERMINE A POSSIBLE CAUSE WITHOUT RETURNED PRODUCT EVAL. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD INFO BECOME AVAILABLE THAT IMPACTS THIS INVESTIGATION. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME.
Description of Event or Problem · 1
A HOSP REPORTED TO SMITHS MEDICAL INTERNATIONAL THAT WHEN THE PACKAGE WAS OPENED, THE DISTAL STOPCOCK WAS DISCONNECTED. THE USER RECONNECTED THE STOPCOCK, BUT THE LUER CONNECTOR DID NOT FIT WELL CAUSING A LEAK IN THE CIRCUIT. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOGICAL 60" SINGLE LINE MONITORING KIT | PRESSURE MONITORING SET | DRS | SMITHS MEDICAL, ASD | NA | 1148626 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |