FDA Adverse Event
Malfunction
Summary report: N
LIFESHIELD BIFURCATED EXTENSION SET
MDR report key: 1001733
·
Received February 19, 2008
Report
- Report Number
- 9615050-2008-00050
- Event Type
- Malfunction
- Date Received
- February 19, 2008
- Date of Event
- January 1, 2008
- Report Date
- January 24, 2008
- Manufacturer
- HOSPIRA DE COSTA RICA LTD.
- Product Code
- FPB
- PMA / PMN Number
- K920736
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES WERE DISCARDED.
Description of Event or Problem · 1
GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF LEAKS; SUBSEQUENTLY BLOOD LOSS WAS NOTED. THE TUBING SETS WERE BEING USED WITH POWER INJECTORS TO DELIVER UNSPECIFIED IODINATED CONTRAST MEDIA AT RATES OF 3ML TO 6ML/SECOND DURING CT ANGIOGRAPHY SCANS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, IT WAS REPORTED THE OPTION LOKS LOOSENED FROM THE PTS' CATHETERS AND UNSPECIFIED AMOUNTS BLOOD AND CONTRAST MEDIA LEAKED. THE CUSTOMER CONTACT REPORTED THAT EITHER THE TUBING SETS WERE RETIGHTENED OR REPLACED AND THE SCANS WERE COMPLETED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESHIELD BIFURCATED EXTENSION SET | 80-FPB | FPB | HOSPIRA DE COSTA RICA LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | UNSPECIFIED IODINATED CONTRAST MEDIA| UNSPECIFIED POWER INJECTOR |