FDA Adverse Event
Other
Summary report: N
STK SCCA 10
MDR report key: 1663782
·
Received April 14, 2010
Report
- Report Number
- 1718850-2010-00082
- Event Type
- Other
- Date Received
- April 14, 2010
- Product Code
- DWF
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SORIN GROUP RECEIVED A MEDWATCH REPORT THAT STATED AN EYELASH WAS SEEN INSIDE A STERILE CARDIOPLEGIA ADAPTER PACKAGE. VISUAL INSPECTION OF THE RETURNED SEAL POUCH CONFIRMED THE PRESENCE OF DEBRIS INSIDE THE PACKAGING THAT HAD THE APPEARANCE OF AN EYELASH. MFG WAS NOTIFIED OF THIS ISSUE AND PERSONNEL HAVE REVIEWED THE PROCEDURES FOR THE FREQUENCY OF SURFACE CLEANING, RAW MATERIAL MOVEMENT AND PROTECTION, AND PROPER HAIR COVERING TECHNIQUES. A NEW VACUUMING SYSTEM SPECIFICALLY MANUFACTURED FOR CONTROLLED CLEAN ROOM ENVIRONMENTS, HAS BEEN TESTED AND ACCEPTED FOR USE IN THE PRODUCTION AREA, TO MINIMIZE THE OCCURRENCE OF PRODUCT DEBRIS.
Description of Event or Problem · 1
.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STK SCCA 10 | STOCK SORIN CORONARY CARDIOPLEGIA ADAPTER (SCCA) | DWF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |