FDA Adverse Event
Malfunction
Summary report: N
CUSTOM PAK
MDR report key: 3061166
·
Received April 10, 2013
Report
- Report Number
- 1644019-2013-00035
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 12, 2013
- Report Date
- March 14, 2013
- Manufacturer
- ALCON - HOUSTON
- Product Code
- KYG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT DURING A VITREORETINAL PROCEDURE, THE LUER LOCK CANNULA DISCONNECTED FROM THE SYRINGE DURING THE INJECTION OF OIL. THE SURGERY TEAM EXCHANGED THE PRODUCT FOR ANOTHER FROM A DIFFERENT LOT NUMBER AND EVERYTHING WORKED FINE. THERE WAS NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149299 | CUSTOM PAK | CONVENIENCE KIT | KYG | ALCON - HOUSTON | CUSTOM PAK | 1353930H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONSTELLATION VISION SYSTEM |