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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 HEYMANN FOLLOWER

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C.R. BARD, INC. (COVINGTON) -1018233 BARD HEYMAN FOLLOWER COUDE TIP 12 FR., STERILE HEYMANN FOLLOWER Back to Search Results
Model Number 021312
Device Problems Incorrect Measurement (1383); Dull, Blunt (2407)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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 heymann follower had a blunt tip instead of a tapered tip. Additional information requested.
 
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Brand NameBARD HEYMAN FOLLOWER COUDE TIP 12 FR., STERILE
Type of DeviceHEYMANN FOLLOWER
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
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7925369
MDR Text Key122461451
Report Number1018233-2018-04511
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 03/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2018
Is this an Adverse Event Report? No
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 Manufacturer09/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2019
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

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