FDA Adverse Event
Malfunction
Summary report: N
PICC KIT 2-LUMEN: 5 FR X 19-5/8IN (50CM)
MDR report key: 3190518
·
Received June 21, 2013
Report
- Report Number
- 1036844-2013-00209
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 30, 2013
- Report Date
- June 21, 2013
- Manufacturer
- ARROW INTL., INC.
- Product Code
- LJS
- PMA / PMN Number
- K061289
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER WAS PLACED OVER THE WIRE AND POSITIONED WITHOUT ISSUE. WHEN THE CLINICIAN ATTEMPTED TO REMOVE THE SPRING WIRE GUIDE, IT FELT "VERY TIGHT" AND WOULD NOT MOVE. AGAIN, THE CLINICIAN ATTEMPTED TO PULL THE WIRE FROM THE CATHETER AND THE WIRE UNRAVELED. AS A RESULT, THE WIRE AND CATHETER WERE REMOVED AS ONE. THE WIRE WAS INTACT BUT STUCK IN THE CATHETER. A NEW KIT WAS OPENED AND PLACED SUCCESSFULLY FOR THE PT. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283779 | PICC KIT 2-LUMEN: 5 FR X 19-5/8IN (50CM) | PERIPHERALLY INSERTED CENTRAL CATHETERS | LJS | ARROW INTL., INC. | RF3014831 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |