FDA Adverse Event
Malfunction
Summary report: N
RECEPTAL 1 LITER
MDR report key: 1358874
·
Received February 16, 2009
Report
- Report Number
- 9613251-2009-00026
- Event Type
- Malfunction
- Date Received
- February 16, 2009
- Date of Event
- January 1, 2009
- Report Date
- February 2, 2009
- Manufacturer
- HOSPIRA, LTD.
- Product Code
- KDQ
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. (B) (4). (B) (4).
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED LOSS OF SUCTION. IT WAS REPORTED THAT DURING TESTING OF THE DEVICE, LOSS OF SUCTION WAS NOTED. THE CUSTOMER CONTACT REPORTED THAT CRACKS WERE NOTED IN THE CENTER AND AROUND THE COVER OF THE LINER. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RECEPTAL 1 LITER | UNK | KDQ | HOSPIRA, LTD. | NA | 68012KZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |