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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 10 FR., STERILE DILATION CATHETER

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C.R. BARD, INC. (COVINGTON) -1018233 BARD HEYMAN FOLLOWER COUDE TIP 10 FR., STERILE DILATION CATHETER Back to Search Results
Catalog Number 021310
Device Problems Incorrect Measurement (1383); Dull, Blunt (2407)
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 has been very blunt instead of having a smooth tapered end. This caused significant damage to urethral tissue. Per additional information from dr. (b)(6). There was no change in the medical management of the patient with 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 10 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 Key7419320
MDR Text Key105102293
Report Number1018233-2018-01156
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 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number021310
Device Lot NumberMCBV3102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2017
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: 04/10/2018 Patient Sequence Number: 1
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