FDA Adverse Event
Malfunction
Summary report: N
SMARTSITE GRAVITY SET
MDR report key: 3023260
·
Received February 27, 2013
Report
- Report Number
- 9616066-2013-00143
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- February 12, 2013
- Report Date
- February 12, 2013
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K820278
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED LEAK. ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED FOR EVAL. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS, SHOULD THE DEVICE BE RECEIVED FOR EVAL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED BLOOD LEAKING FROM THE SMARTSITE. THE PT WAS TRANSFERRED FROM THE OPERATING ROOM TO RECOVERY ROOM AND UPON ARRIVAL, THE NURSE LOOKED AT THE IV SITE AND NOTICED BLOOD ON THE BED. THE BLOOD WAS LEAKING FROM THE SMARTSITE CLOSEST TO THE PT. THE NURSE CAPED OFF SMARTSITE TO STOP THE LEAKING AND CONTINUED USING THE IV SET. THE HOSPITAL USES MONOJECT SYRINGES. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. NO FURTHER PT OR EVENT DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85335 | SMARTSITE GRAVITY SET | FPA | CAREFUSION CORPORATION | 42493E | 13015895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | THERAPY DATE:| MONOJECT SYRINGE: MFR, MODEL, AND LOT # UNKNOWN |