FDA Adverse Event
Malfunction
Summary report: N
PER-Q-CATH PLUS 2F SL PICC W/STIFFENING STYLET BASIC TRAY
MDR report key: 4102722
·
Received August 28, 2014
Report
- Report Number
- 3006260740-2014-00441
- Event Type
- Malfunction
- Date Received
- August 28, 2014
- Date of Event
- August 3, 2014
- Report Date
- August 12, 2014
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- LJS
- PMA / PMN Number
- K954104
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REXG1000 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THESE LOT NUMBERS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CENTRAL CATHETER OF PERIPHERAL INSERTION WAS INSTALLED ON (B)(6) 2014 AT THE LOWER RIGHT MEMBER IN THE NEWBORN NEONATAL AT THE ICU, AND ON (B)(6) 2014 THE PT WAS WITH THE REGION OF THE PUNCTION AND MEMBER SWOLLEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 526827 | PER-Q-CATH PLUS 2F SL PICC W/STIFFENING STYLET BASIC TRAY | LJS | BARD ACCESS SYSTEMS | REXG1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 YR |