MILLEX-OR MILLEX - .22U SLGL0250S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2005-07-27 for MILLEX-OR MILLEX - .22U SLGL0250S manufactured by Millipore Corp..

Event Text Entries

[35463745] The product labeling for millex - or sterilizing filters clearly states 'do not use with syringes smaller than 10cc'. Unfortunately, a 2cc syringe was used during the complaint event procedure. The 2cc syringe caused the need for over tightening and fluid pressure buildup. Use of a syringe 10cc (or greater) would eliminate the need for over tightening and reduce the fluid pressure within the device assembly. Since the millex - or filter reference in (b)(4) was 'misused' according to product label statements, there is no corrective action planned at this time.
Patient Sequence No: 1, Text Type: N, H10


[35463746] During cataract surgery, the millex-or sterilizing filter (with dispensing tip) detached from the syringe and with force was projected into the patient's eye.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020892-2005-00001
MDR Report Key5353249
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2005-07-27
Date of Report2005-07-27
Date of Event2005-05-24
Date Mfgr Received2005-06-23
Device Manufacturer Date2004-11-01
Date Added to Maude2016-01-08
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 ContactJOHN ASTARITA
Manufacturer Street80 ASHBY RD.
Manufacturer CityBEDFORD MA 01730
Manufacturer CountryUS
Manufacturer Postal01730
Manufacturer Phone7815332484
Manufacturer G1MILLIPORE IRELAND B.V.
Manufacturer CityCARRIGTWOHOLL CO. CORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMILLEX-OR
Generic NameSTERILIZING FILTER
Product CodeJRL
Date Received2005-07-27
Returned To Mfg2005-07-01
Model NumberMILLEX - .22U
Catalog NumberSLGL0250S
Lot NumberR4PN91767
Device Expiration Date2007-11-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMILLIPORE CORP.
Manufacturer AddressBILLERICA MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2005-07-27

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