FDA Adverse Event
Malfunction
Summary report: N
PA EMPTY STERILE
MDR report key: 2755363
·
Received September 19, 2012
Report
- Report Number
- 1021343-2012-00068
- Event Type
- Malfunction
- Date Received
- September 19, 2012
- Date of Event
- August 1, 2012
- Report Date
- August 31, 2012
- Manufacturer
- HOSPITA, INC.
- Product Code
- MEA
- PMA / PMN Number
- K043256
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED A LEAK. ON AN UNSPECIFIED DATE, IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED DURING MANUAL FILLING OF THE VIAL AT THE USER FACILITY. THE CUSTOMER CONTACT REPORTED THE VIAL WAS BEING FILLED WITH AN UNSPECIFIED CONCENTRATION OF HYDROMORPHONE WHEN SOLUTION LEAKED ABOVE THE LUER SITE ON THE INJECTOR IN THE VIAL. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PA EMPTY STERILE | 80MEA | MEA | HOSPITA, INC. | NA | 16248R1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |