FDA Adverse Event
Malfunction
Summary report: N
PICC KIT 2-LUMEN: 5 FR X 19-5/8 (50 CM)
MDR report key: 2241161
·
Received August 17, 2011
Report
- Report Number
- 1036844-2011-00270
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- May 29, 2011
- Report Date
- August 3, 2011
- Manufacturer
- ARROW INTL., INC.
- Product Code
- LJS
- PMA / PMN Number
- K061289
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED VIA A MAUDE ADVERSE EVENT REPORT THAT THE EVENT INVOLVED A FEMALE PT, DURING PLACEMENT OF A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE, BY THE USUAL METHOD. PLACEMENT WAS CONFIRMED BY X-RAY. WHEN PULLING THE SPRING WIRE GUIDE (SWG) OUT , RESISTANCE WAS NOTED; THE SWG COULD NOT BE REMOVED. THE PICC LINE WAS DISCONTINUED DUE TO THIS PROBLEM. THE COVERING OF THE SWG WAS NOTED TO BE UNRAVELING WHEN THE LINE WAS PULLED. THE PT WAS RESCHEDULED FOR PICC LINE PLACEMENT. THIS WILL EXTEND HER HOSPITAL STAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PICC KIT 2-LUMEN: 5 FR X 19-5/8 (50 CM) | PERIPHERALLY INSERTED CENTRAL CATHETERS | LJS | ARROW INTL., INC. | FR0018012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |