FDA Adverse Event
Malfunction
Summary report: N
SMARTSITE EXTENSION SET
MDR report key: 3170779
·
Received May 22, 2013
Report
- Report Number
- 9616066-2013-00377
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Date of Event
- May 7, 2013
- Report Date
- May 8, 2013
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K811885
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY NOTICED A LEAK FROM A "CRACK ON THE LUER HUB" AT THE START OF THE INFUSION. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT. NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226416 | SMARTSITE EXTENSION SET | FPA | CAREFUSION CORP. | 30852 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |