FDA Adverse Event
Malfunction
Summary report: N
GUARDIAN PICC
MDR report key: 2168389
·
Received July 11, 2011
Report
- Report Number
- 2168389
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- January 22, 2011
- Report Date
- July 11, 2011
- Manufacturer
- MARIAN MEDICAL, INC.
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- SD, US
Narratives
Description of Event or Problem · 1
GUARDIAN PICC LINE BROKE BETWEEN THE BUTTERFLY SITE AND THE HUB. THE FAMILY HAD PLACED THE PATIENT BACK INTO THE CRIB WHEN THE EVENT OCCURRED. FAMILY CALLED RN TO BEDSIDE AS SHE USED HER HAND AS A TOURNIQUET AROUND THE INFANT'S LEG, AS SHE DID NOT KNOW IF THE LINE HAD MIGRATED OR NOT. ANOTHER RN AT THE BEDSIDE WAS ABLE TO FIND THE TIP OF THE CATHETER WHICH WAS REMOVED PER PROTOCOL USING A HEMOSTAT. PRESSURE WAS HELD TO THE SITE FOR FIVE MINUTES AND THEN THE SITE WAS CLEANED PER PROTOCOL. THE NNP WAS CALLED TO THE BEDSIDE STAT WHEN THE INCIDENT OCCURRED AND WAS ABLE TO CONFIRM THE ENTIRE LENGTH OF THE PICC HAD BEEN REMOVED PER MEASUREMENT. NO INJURY TO THE INFANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUARDIAN PICC | CATHETER, PICC | LJS | MARIAN MEDICAL, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 DAY | OTHER |