FDA Adverse Event
Malfunction
Summary report: N
NDHP KINK RSTNT YSIT
MDR report key: 1944227
·
Received December 6, 2010
Report
- Report Number
- 9613251-2010-00173
- Event Type
- Malfunction
- Date Received
- December 6, 2010
- Date of Event
- November 12, 2010
- Report Date
- November 12, 2010
- Manufacturer
- HOSPIRA LTD.
- Product Code
- FPK
- PMA / PMN Number
- K941214
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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. DURING TESTING AT THE USER FACILITY, IT WAS REPORTED THAT WHEN THE TUBING WAS "GENTLY TUGGED", THE TUBING SEPARATED FROM THE ARM OF THE CLAVE Y-SITE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NDHP KINK RSTNT YSIT | 80FPK | FPK | HOSPIRA LTD. | NA | 89095NS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |