FDA Adverse Event
Malfunction
Summary report: N
CUSTOM PAK
MDR report key: 3963344
·
Received May 21, 2014
Report
- Report Number
- 1644019-2014-00095
- Event Type
- Malfunction
- Date Received
- May 21, 2014
- Date of Event
- April 23, 2014
- Report Date
- April 28, 2014
- Manufacturer
- ALCON - HOUSTON
- Product Code
- KYG
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED BY A COMPANY REPRESENTATIVE AND IT IS IN TRANSIT TO THE MANUFACTURER FOR INVESTIGATION. 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 THE VALVED TROCAR CANNULA STAYED OPENED WHEN INSERTED TO THE PATIENT'S EYE DURING A VITREORETINAL PROCEDURE. VITREOUS HUMOUR LEAKED BECAUSE THE VALVE WAS NOT CLOSED THE WHOLE TIME DURING THE SURGERY. THE ISSUE WAS RESOLVED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT CONSEQUENCES TO THE PATIENT. A PRODUCT SAMPLE HAS BEEN REQUESTED FOR THIS CASE FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301422 | CUSTOM PAK | CONVENIENCE KIT | KYG | ALCON - HOUSTON | CUSTOM PAK | 1500441H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |