FDA Adverse Event
Injury
Summary report: N
2-SITE ADMIN SET W/5.0" EXFEN
MDR report key: 1013686
·
Received March 13, 2008
Report
- Report Number
- 1811755-2008-00010
- Event Type
- Injury
- Date Received
- March 13, 2008
- Date of Event
- February 9, 2007
- Report Date
- February 13, 2008
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- FPA
- PMA / PMN Number
- K043466
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVAL. IN ADDITION, NO LOT NUMBER COULD BE PROVIDED.
Description of Event or Problem · 1
STUDY COORDINATOR REPORTED TO STRYKER IN 2008 THAT FOLLOWING A STERNOTOMY IN 2006 , PT WORE A PAINPUMP FOR POST-OP PAIN RELIEF WHERE 0.3% ROPIVACAINE WAS INFUSED AT 4.0ML/HOUR AND THE PUMP WAS IN PLACE FOR 64 HOURS. IN 2007, PT HAD A REPEAT MEDIAN STERNOTOMY AND DRAINAGE OF MEDIASTINAL ABSCESS. A PICC LINE WAS PLACED ON FOUR DAYS LATER. PT WAS TREATED WITH VANCOMYCIN AND ANCEF. PT WAS ALSO EXPECTED TO BE PUT ON A SUPPRESSION THERAPY WITH AN ORAL ANTIBIOTIC OF MINOCYCLINE. THE SURGEON REPORTED TO THE STUDY COORDINATOR THAT HE COULD NOT RULE OUT THE PUMP AS A FACTOR IN THIS REPORTED INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2-SITE ADMIN SET W/5.0" EXFEN | INFUSION PUMP CATHETER SET | FPA | STRYKER INSTRUMENTS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |