FDA Adverse Event
Malfunction
Summary report: N
COMPLETELY PROGRAMMABLE PUMP W/STANDARD & 5.0" EXP
MDR report key: 3152052
·
Received March 23, 2009
Report
- Report Number
- 2648666-2009-00056
- Event Type
- Malfunction
- Date Received
- March 23, 2009
- Date of Event
- February 20, 2009
- Report Date
- February 23, 2009
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FRN
- PMA / PMN Number
- K042405
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER WAS DISCARDED BY THE PATIENT AND WAS UNABLE TO BE INVESTIGATED. ACCORDING TO THE INFORMATION THAT WAS RECEIVED FROM THE PATIENT, THE CATHETER WAS ABLE TO BE REMOVED BY HAND AND THERE WAS NO NEED FOR A SECONDARY PROCEDURE OR ADDITIONAL PAIN MEDICATION PRESCRIBED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT FOLLOWING A SHOULDER PROCEDURE THE CATHETER TUBING BROKE IN HALF WHILE THEY WERE TURNING OVER IN BED. THE BROKEN PORTION OF THE CATHETER WAS ABLE TO BE REMOVED BY HAND AND THERE WAS NO NEED FOR ANY ADDITIONAL PROCEDURES OR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPLETELY PROGRAMMABLE PUMP W/STANDARD & 5.0" EXP | INFUSION PUMP | FRN | STRYKER INSTRUMENTS KALAMAZOO | 09017012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |