FDA Adverse Event
Malfunction
Summary report: N
SECONDARY SET 34IN NDEHP
MDR report key: 1934432
·
Received November 23, 2010
Report
- Report Number
- 9613251-2010-00160
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- October 29, 2010
- Report Date
- November 1, 2010
- Manufacturer
- HOSPIRA LTD.
- Product Code
- FPA
- PMA / PMN Number
- K052722
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, 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 UNRESTRICTED FLOW. PRIOR TO PT USE, THE CUSTOMER CONTACT REPORTED THAT AFTER THE CAIR CLAMP WAS CLOSED, NORMAL SALINE CONTINUED TO DRIP IN THE DRIP CHAMBER AND FLOW WAS NOTED FROM THE DISTAL END OF THE TUBING SET. 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 | SECONDARY SET 34IN NDEHP | 80FPA | FPA | HOSPIRA LTD. | NA | 892414W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |