FDA Adverse Event
Malfunction
Summary report: N
RC MOD/5.2F/100CM/ST+
MDR report key: 1030575
·
Received April 14, 2008
Report
- Report Number
- 9616099-2008-00989
- Event Type
- Malfunction
- Date Received
- April 14, 2008
- Date of Event
- February 25, 2008
- Report Date
- March 18, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- DQO
- PMA / PMN Number
- K862244
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PLEASE NOTE THAT THE PRODUCT IS NOT AVAILABLE FOR EVAL. HOWEVER, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN. THIS IS ONE OF NINE PRODUCTS INVOLVED IN THE SAME EVENT AND REPORTED UNDER MFG NUMBERS: 9616099-2008-00978, 00981, 00983, 00984, 00985, 00986, 00987, AND 00988.
Description of Event or Problem · 1
THE REPORT RECEIVED INDICATED THAT DURING A VISUAL EXAMINATION OF THE PRODUCT, THE CUSTOMER IDENTIFIED THE PRESENCE OF STRANDS AND PARTICLES. FURTHER INFO INDICATED THE PROBLEM WAS VISIBLE THROUGH THE STERILE POUCH, AS SUCH, THE DEVICES WERE NOT REMOVED FROM THE STERILE POUCH. THERE WERE NO ANOMALIES NOTED WITH THE PACKAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RC MOD/5.2F/100CM/ST+ | DIAGNOSTIC CARDIOLOGY CATHETER (DQO) | DQO | CORDIS DE MEXICO | NA | 13276202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |