FDA Adverse Event
Malfunction
Summary report: N
PLUM LC OL CNVRTBL P
MDR report key: 1925820
·
Received November 8, 2010
Report
- Report Number
- 9615050-2010-00223
- Event Type
- Malfunction
- Date Received
- November 8, 2010
- Date of Event
- March 1, 2010
- Report Date
- March 26, 2010
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K865060
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL; (B)(4).
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED A SEPARATION. PRIOR TO PT USE WHILE PRIMING THE TUBING SET WITH AN UNSPECIFIED SOLUTION, IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE ARM OF THE CLAVE Y-SITE. THERE WAS NO REPORTED DELAY IN CRITICAL THERAPY. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUM LC OL CNVRTBL P | 80 FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | UNK5H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |