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,foreig report with the FDA on 2018-02-21 for ROUND FILTERS W/INDICATOR US751 manufactured by Sps Medical Supply Corp.

Event Text Entries

[100783775] (b)(4). Manufacturing site evaluation: evaluation on-going device not returned.
Patient Sequence No: 1, Text Type: N, H10


[100783776] Country of complaint: usa hospital employee did not check filters before taking the container into the steril field during the setup process. Patient had been given a paralytic before surgery. Before the patient had been opened, it was noticed in the or that the filters contained holes going all the way through the filters which matched the pattern of the holes in the container. They did not have another set available, so they had to cancel surgery all med watch submissions related to this report are: 2916714-2018-00004, 2916714-2018-00005.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916714-2018-00005
MDR Report Key7287218
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-02-21
Date of Report2018-02-21
Date of Event2018-01-23
Date Facility Aware2018-01-29
Date Mfgr Received2018-01-25
Date Added to Maude2018-02-21
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. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1SPS MEDICAL SUPPLY CORP
Manufacturer Street6789 W HENRIETTA RD MONROE
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 CodeKCT
Date Received2018-02-21
Model NumberUS751
Catalog NumberUS751
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSPS MEDICAL SUPPLY CORP
Manufacturer Address6789 W HENRIETTA RD MONROE RUSH NY 14543 US 14543


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-02-21

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