PROXIS? URETERAL ACCESS SHEATH 231225

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-12 for PROXIS? URETERAL ACCESS SHEATH 231225 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[120119663] The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10


[120119664] It was reported that there was plastic coming out of the inside of the sheath. The plastic found inside of the sheath was not part of the device. There was no reported patient impact.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2018-04133
MDR Report Key7868012
Date Received2018-09-12
Date of Report2019-01-23
Date Mfgr Received2019-01-08
Device Manufacturer Date2018-02-19
Date Added to Maude2018-09-12
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 ContactYONIC ANDERSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePROXIS? URETERAL ACCESS SHEATH
Generic NamePROXIS ACCESS SHEATH
Product CodeFED
Date Received2018-09-12
Returned To Mfg2018-09-12
Model Number231225
Catalog Number231225
Lot NumberBMCPFM06
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-12

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