FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ 3.13 SINGLE C
MDR report key: 3113156
·
Received May 8, 2013
Report
- Report Number
- 9615050-2013-01107
- Event Type
- Malfunction
- Date Received
- May 8, 2013
- Date of Event
- March 26, 2013
- Report Date
- March 26, 2013
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K110901
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
DURING VERIFICATION TESTING AT THE SVC CTR, THE DEVICE DELIVERED LESS THAN EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200234 | SYMBIQ 3.13 SINGLE C | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |