FDA Adverse Event
Malfunction
Summary report: N
RECEPTAL 1 LITER
MDR report key: 1423145
·
Received March 19, 2009
Report
- Report Number
- 9613251-2009-00093
- Event Type
- Malfunction
- Date Received
- March 19, 2009
- Date of Event
- September 22, 2008
- Report Date
- February 17, 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
ONE USED DEVICE WAS EVALUATED. TESTING FOUND THE LINER LID WAS CRACKED. THIS WAS DUE TO THE LID SEALING SINK PARAMETER.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED LOSS OF SUCTION. IT WAS REPORTED THAT DURING TESTING OF THE DEVICE WHEN SUCTION WAS APPLIED, CRACKS WERE NOTED ON THE LID OF THE LINER; SUBSEQUENTLY, LOSS OF SUCTION WAS NOTED. THE LINER WAS REPLACED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RECEPTAL 1 LITER | UNK | KDQ | HOSPIRA LTD. | NA | 62096KZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |