ISPAN GAS TANK REGULATOR 8065797303

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-15 for ISPAN GAS TANK REGULATOR 8065797303 manufactured by Air Liquide.

Event Text Entries

[133206719] No sample has been received by manufacturing for evaluation. 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. Additional information has been requested. This is the first of two reports for this reported event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[133206720] A director of nurses reported that an ophthalmic gas and gas dispensing regulator valve were both used during a pars plana vitrectomy (ppv), membrane peel (mp) and internal limiting membrane (ilm) procedure. The instilled gas bubble was not successfully retained inside of the patient's eye. Additional information was requested and received. There was no impact to the patient and no additional treatment or intervention was required.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1610287-2019-00001
MDR Report Key8248371
Date Received2019-01-15
Date of Report2019-03-13
Date of Event2018-11-26
Date Mfgr Received2019-03-04
Device Manufacturer Date2017-08-09
Date Added to Maude2019-01-15
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 ContactMS. CINDY MILAM
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152231
Manufacturer G1AIR LIQUIDE
Manufacturer Street13140 TI BLVD.
Manufacturer CityDALLAS TX 75243
Manufacturer CountryUS
Manufacturer Postal Code75243
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameISPAN GAS TANK REGULATOR
Generic NameINTRAOCULAR GAS
Product CodeLPO
Date Received2019-01-15
Returned To Mfg2018-12-21
Model NumberNA
Catalog Number8065797303
Lot Number722120
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAIR LIQUIDE
Manufacturer Address13140 TI BLVD. DALLAS TX 75243 US 75243


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-15

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