ROUND FILTERS W/INDICATOR US751

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-17 for ROUND FILTERS W/INDICATOR US751 manufactured by Contract Manufacturer: Sps Medical Supply Corp.

Event Text Entries

[130622266] Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[130622267] It was reported that the indicators on filters were not changing color. The indicators on filters used for instrument containers were not functioning as intended. It was felt that they were not discoloring as they should. There was no patient involvement or harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916714-2018-00045
MDR Report Key8171654
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-12-17
Date of Report2019-01-30
Date of Event2018-11-29
Date Facility Aware2019-01-25
Date Mfgr Received2019-01-25
Date Added to Maude2018-12-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145515988
Manufacturer G1CONTRACT MANUFACTURER: SPS MEDICAL SUPPLY CORP
Manufacturer Street6789 W HENRIETTA ROAD
Manufacturer CityRUSH NY 14543
Manufacturer CountryUS
Manufacturer Postal Code14543
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameROUND FILTERS W/INDICATOR
Generic NameSTERILE TECHNOLOGY
Product CodeJOJ
Date Received2018-12-17
Model NumberUS751
Catalog NumberUS751
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONTRACT MANUFACTURER: SPS MEDICAL SUPPLY CORP
Manufacturer Address6789 W HENRIETTA ROAD RUSH NY 14543 US 14543


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-17

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