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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 14 FR., STERILE DILATION CATHETER

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C.R. BARD, INC. (COVINGTON) -1018233 BARD HEYMAN FOLLOWER COUDE TIP 14 FR., STERILE DILATION CATHETER Back to Search Results
Model Number 021314
Device Problems Incorrect Measurement (1383); Dull, Blunt (2407)
Patient Problems Tissue Damage (2104); Injury (2348)
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 has caused significant damage to the urethral tissue. Per additional information from dr. (b)(6). There was no change in the medical management of the patient who 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 14 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 Key7516092
MDR Text Key108317389
Report Number1018233-2018-01758
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 07/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number021314
Device Catalogue Number021314
Device Lot NumberMCBW3409
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 Received07/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2017
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: 05/15/2018 Patient Sequence Number: 1
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