VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT) 8065750957

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-22 for VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT) 8065750957 manufactured by Alcon Research, Ltd. - Houston.

Event Text Entries

[124674638] 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. A product sample has been received by the manufacturer and it is awaiting evaluation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[124674639] A materials coordinator reported when surgeon "hit the foot pedal to inject the silicone", the cannula disconnect and the silicone spilled during a vitrectomy procedure. The product was replaced and the procedure was completed with no harm to the patient. No additional information is expected.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644019-2018-00247
MDR Report Key7992492
Date Received2018-10-22
Date of Report2019-01-15
Date of Event2018-09-28
Date Mfgr Received2018-12-21
Device Manufacturer Date2018-01-17
Date Added to Maude2018-10-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BRYAN BLAKE
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152231
Manufacturer G1ALCON RESEARCH, LTD. - HOUSTON
Manufacturer Street9965 BUFFALO SPEEDWAY
Manufacturer CityHOUSTON TX 77054
Manufacturer CountryUS
Manufacturer Postal Code77054
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameVISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT)
Generic NameTUBING, NONINVASIVE
Product CodeGAZ
Date Received2018-10-22
Returned To Mfg2018-10-19
Model NumberNA
Catalog Number8065750957
Lot Number2108641H
Device Expiration Date2019-12-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LTD. - HOUSTON
Manufacturer Address9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-22

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