FDA Adverse Event
Malfunction
Summary report: N
SMALLBORE QUADFUSE EXTENSION SET
MDR report key: 5967646
·
Received September 21, 2016
Report
- Report Number
- 9616066-2016-01273
- Event Type
- Malfunction
- Date Received
- September 21, 2016
- Date of Event
- August 31, 2016
- Report Date
- August 31, 2016
- Manufacturer
- CAREFUSION
- Product Code
- FPA
- PMA / PMN Number
- K790108
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER¿S COMPLAINT OF TPN LEAKING FROM THE CONNECTION OF AN IV PORT MATED TO A NON-CAREFUSION/BD CONNECTOR WAS NOT CONFIRMED. FUNCTIONAL TESTING FAILED TO PRODUCE A LEAK WITHIN THE ADMINISTRATION SET. PRESSURE TESTING ALSO FOUND NO FAULT WITH THE RECEIVED SET. THE ROOT CAUSE OF THE LEAK WAS NOT IDENTIFIED
Description of Event or Problem · 1
THE CUSTOMER REPORTED TPN LEAKED AT THE CONNECTION OF A QUAD-FUSE PORT TO A NON-CAREFUSION/BD CONNECTOR. THE TUBING WAS CHANGED AND THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 620086 | SMALLBORE QUADFUSE EXTENSION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | CAREFUSION | 10015817 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 DA | 8110,8015,SPMTUBING,(4)ICUMEDICALCLAVE |