FDA Adverse Event
Malfunction
Summary report: N
FIRST PICC
MDR report key: 2233104
·
Received July 26, 2011
Report
- Report Number
- 1625425-2011-00119
- Event Type
- Malfunction
- Date Received
- July 26, 2011
- Date of Event
- June 30, 2011
- Report Date
- July 25, 2011
- Manufacturer
- ARGON MEDICAL DEVICES INC.
- Product Code
- FOZ
- PMA / PMN Number
- K944504
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE LINE WAS PLACED BY NURSE WITH NO DIFFICULTY. THE NURSE WENT TO MAKE ASSESSMENT AND FOUND HUB LAYING IN BED BROKEN APPROXIMATELY 1 CM BELOW THE HUB. LINE WAS PULLED FROM INFANT AND X-RAYS WERE COMPLETED TO VERIFY NO RESIDUAL LINE BROKEN WITHIN INFANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIRST PICC | FOZ | ARGON MEDICAL DEVICES INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |