FDA Adverse Event
Malfunction
Summary report: N
OEC DISPOSABLE PACK
MDR report key: 1441870
·
Received August 13, 2009
Report
- Report Number
- 1441870
- Event Type
- Malfunction
- Date Received
- August 13, 2009
- Date of Event
- August 12, 2009
- Report Date
- August 13, 2009
- Manufacturer
- ADVANCED MEDICAL DESIGNS, INC
- Product Code
- KKX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VT, US
Narratives
Description of Event or Problem · 1
SPD TECHNICIAN WENT TO PICK OEC C-ARM DISPOSABLE PACK FROM SHELF AND NOTICED THAT STERILE PACKAGING WAS NOT SEALED. TECHNICIAN THEN INSPECTED OTHER PACKS AND FOUND ANOTHER PACK WITH DEFECTIVE SEAL.THESE TWO UNITS WERE REMOVED FROM SERVICE. SEALS ON OTHER UNITS FROM SAME LOT WERE NOT DEFECTIVE.MANUFACTURER HAS BEEN NOTIFIED AND HAS REQUESTED DEFECTIVE PACKS BE RETURNED TO MANUFACTURER. MANUFACTURER RESPONSE (AS PER REPORTER) FOR C-ARM DRAPE, OEC DISPOSABLE PACKMANUFACTURER REQUESTED THAT PRODUCT BE RETURNED TO MANUFACTURER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OEC DISPOSABLE PACK | DRAPE, C-ARM | KKX | ADVANCED MEDICAL DESIGNS, INC | 07-PK800 | 81062C8122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |