FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 4 FR X 19-1/2
MDR report key: 3190555
·
Received June 21, 2013
Report
- Report Number
- 1036844-2013-00207
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- August 28, 2012
- Report Date
- June 20, 2013
- Manufacturer
- ARROW INTL., INC.
- Product Code
- LJS
- PMA / PMN Number
- K042126
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- UNKNOWN
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 IN RADIOLOGY AFTER THE PICC WAS INSERTED, THE USER BROKE THE ORANGE WINGS AND BEGAN PEELING AWAY THE WHITE MATERIAL OF THE INTRODUCER. IT WAS AT THAT TIME, DURING THE REMOVAL, THE SHEATH BEGAN TO TEAR. AS A RESULT, THE REMAINDER OF THE INTRODUCER HAD TO BE CAREFULLY REMOVED, PROLONGING THE PROCEDURE/
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282723 | CVC SET: 4 FR X 19-1/2 | PERIPHERAL CATHETER PRODUCTS | LJS | ARROW INTL., INC. | RF1093871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |