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 2019-05-07 for ROUND FILTERS W/INDICATOR US751 manufactured by Sps Medical Supply Corp.

Event Text Entries

[144966739] Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report. Investigation on-going.
Patient Sequence No: 1, Text Type: N, H10


[144966740] It was reported that there was an issue with the round filters. While preparing instrument packages prior to surgery, pin-size holes were found in the filters, which are sterility indicators. There was no patient harm or intervention required; however, a delay of up to 30 minutes was noted. Additional information was not available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916714-2019-00010
MDR Report Key8588741
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-07
Date of Report2019-05-07
Date of Event2019-03-11
Date Facility Aware2019-03-11
Date Mfgr Received2019-03-11
Date Added to Maude2019-05-07
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. LINDSAY CHROMIAK
Manufacturer Street3773 CORPORATE PARKWAY
Manufacturer CityCENTER VALLEY PA 18034
Manufacturer CountryUS
Manufacturer Postal18034
Manufacturer G1SPS MEDICAL SUPPLY CORP
Manufacturer Street6789 W HENRIETTA RD
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 CodeFRG
Date Received2019-05-07
Model NumberUS751
Catalog NumberUS751
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSPS MEDICAL SUPPLY CORP
Manufacturer Address6789 W HENRIETTA RD RUSH NY 14543 US 14543


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-07

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