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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (MONCKS) -1030583 BARD® WEBER RECTAL CATHETER
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C.R. BARD, INC. (MONCKS) -1030583 BARD® WEBER RECTAL CATHETER Back to Search Results
Catalog Number 0006580
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).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.The device was not returned.
 
Event or Problem Description
It was reported that the device would not infuse during pretesting.
 
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Brand Name
BARD® WEBER RECTAL CATHETER
Common Device Name
RECTAL CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (MONCKS) -1030583
428 power house rd
moncks corner SC 29461
MDR Report Key6562171
Report Number1018233-2017-02398
Device Sequence Number13733761
Product Code KNT
UDI-Device Identifier10801741122177
UDI-Public(01)10801741122177
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
PRE-AMEND
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 05/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Catalogue Number0006580
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/21/2017
Initial Report FDA Received Date05/11/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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