FDA Adverse Event
Other
Summary report: N
PHASEAL INFUSION ADAPTER
MDR report key: 1210282
·
Received October 22, 2008
Report
- Report Number
- 9615998-2008-00006
- Event Type
- Other
- Date Received
- October 22, 2008
- Date of Event
- September 29, 2008
- Report Date
- October 20, 2008
- Manufacturer
- CARMEL PHARMA AB,
- Product Code
- LHI
- PMA / PMN Number
- K023747
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INITIATED. ON-GOING ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION REGARDING THE REPORTED INCIDENT.
Description of Event or Problem · 1
"A NURSE RECEIVED AN INFUSION BAG OF IRINOTECAN, WITH THE INFUSION ADAPTER ATTACHED BY PHARMACY. THE NURSE OPENED THE FLAP ON THE INFUSION ADAPTER IN ORDER TO SPIKE WITH THE IV TUBING AND THE MEDICATION SPLASHED OUT OF THE DISTAL END OF THE INFUSION ADAPTER. THE NURSE WAS SPLASHED WITH MEDICATION ON HER FACE AND IN HER EYES. EXPOSURE PROTOCOL WAS FOLLOWED WITH FLUSH AND EYEWASH. NURSE STATES NO INJURY OCCURRED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHASEAL INFUSION ADAPTER | INTRAVASCUALR ADMINISTRATION SET | LHI | CARMEL PHARMA AB, | C100 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |