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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD HEYMAN FOLLOWER COUDE TIP 12 FR., STERILE DILATION CATHETER

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C.R. BARD, INC. (COVINGTON) -1018233 BARD HEYMAN FOLLOWER COUDE TIP 12 FR., STERILE DILATION CATHETER Back to Search Results
Model Number 021312
Device Problems Incorrect Measurement (1383); Dull, Blunt (2407); Structural Problem (2506)
Patient Problem Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
It was reported that the tip was very blunt instead of having a smooth tapered end. The patient alleged significant damage to the urethral tissue. There was no change in the medical management of a patient that has a more traumatic dilation (damage to urethral tissue), except to leave the post-dilation catheter in longer.
 
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Brand NameBARD HEYMAN FOLLOWER COUDE TIP 12 FR., STERILE
Type of DeviceDILATION CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7519796
MDR Text Key108451607
Report Number1018233-2018-01778
Device Sequence Number1
Product Code FBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number021312
Device Catalogue Number021312
Device Lot NumberMCBV6209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/16/2018 Patient Sequence Number: 1
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