FDA Adverse Event
Other
Summary report: N
PHASEAL INFUSION ADAPTER
MDR report key: 1420442
·
Received May 21, 2009
Report
- Report Number
- 9615998-2009-00008
- Event Type
- Other
- Date Received
- May 21, 2009
- Date of Event
- December 1, 2008
- Report Date
- May 19, 2009
- Manufacturer
- CARMEL PHARMA AB.
- Product Code
- LHI
- PMA / PMN Number
- K023747
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PHASEAL INFUSION ADAPTER C100 IS DESIGNED IN ACCORDANCE WITH THE REQUIREMENTS OF INTERNATIONAL STANDARDS, (B) (4). THE HOLDING FORCE BETWEEN THE PHASEAL INFUSION ADAPTER C100 AND PORTS OF VARIOUS INFUSION CONTAINERS HAS BEEN TESTED AND FOUND TO BE IN ACCORDANCE WITH STANDARD REQUIREMENTS.
Description of Event or Problem · 1
REPORT OF INFUSION ADAPTER FALLING OUT OF INFUSION BAG PORT. CHEMO SPILLED AND A SMALL AMOUNT WAS SPLASHED ONTO PHARMACY TECH'S FACE AND EYES. HOSPITAL PROTOCOL WAS FOLLOWED AND THERE ARE NO RESIDUAL EFFECTS OF THE SPILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHASEAL INFUSION ADAPTER | INTRAVASCULAR ADMINISTRATION SET | LHI | CARMEL PHARMA AB. | C100 | 8420439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |