FDA Adverse Event
Malfunction
Summary report: N
2100 ML LINER W/EXTERNAL VALVE
MDR report key: 1002617
·
Received February 8, 2008
Report
- Report Number
- 9613251-2008-00031
- Event Type
- Malfunction
- Date Received
- February 8, 2008
- Date of Event
- January 15, 2008
- Report Date
- January 15, 2008
- Manufacturer
- HOSPIRA LTD.
- Product Code
- GCX
- PMA / PMN Number
- K893741
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. A REP DEVICE FROM THE LOT NUMBERS 53001KZ AND 54105KZ WAS RECEIVED. INVESTIGATION IS NOT COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED LOSS OF SUCTION. DURING TESTING AT THE USER FACILITY, THE HEALTHCARE PROFESSIONAL REPORTED THAT THE SUCTION LINER "IMPLODED". LOSS OF SUCTION WAS NOTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2100 ML LINER W/EXTERNAL VALVE | 79-GCX | GCX | HOSPIRA LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |