FDA Adverse Event
Malfunction
Summary report: N
2-GANG 4-WAY STOPCOCK W/ SWIVEL MALE LUER LOC
MDR report key: 1021520
·
Received March 26, 2008
Report
- Report Number
- 9616567-2008-00019
- Event Type
- Malfunction
- Date Received
- March 26, 2008
- Report Date
- February 25, 2008
- Manufacturer
- SMITHS MEDICAL, ASD
- Product Code
- FMG
- PMA / PMN Number
- PREAMEND
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
SAMPLES HAVE BEEN RECEIVED FROM THE CUSTOMER; HOWEVER, SMITHS HAS NOT YET COMPLETED THE INVESTIGATION INTO THIS ISSUE. A FOLLOW UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE "IV TUBING 3-WAY CONNECTORS AND THE IV TUBING WERE NOTED TO HAVE BLOOD BACKED UP FROM THE CENTRAL ACCESS INTO THE CONNECTORS AND IV TUBING. HEPARIN, FENTANYL, AND INSULIN GTTS WAS INFUSING THROUGH THE LINE. THE PRODUCT SNAPPED AT THE CONNECTION...PRODUCT BROKE IN THE MIDDLE. VASOPRESSORS WERE RUNNING INTO THE BED. THE PATIENT EXPERIENCED A HYPOTENSIVE EPISODE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2-GANG 4-WAY STOPCOCK W/ SWIVEL MALE LUER LOC | STOPCOCKS | FMG | SMITHS MEDICAL, ASD | NA | 1204123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |