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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD HEYMAN FOLLOWERS COUDE TIP, COMPLETE SET 10-24 FR., STERILE

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C.R. BARD, INC. (COVINGTON) -1018233 BARD HEYMAN FOLLOWERS COUDE TIP, COMPLETE SET 10-24 FR., STERILE Back to Search Results
Model Number 021300
Device Problems Inadequate Instructions for Healthcare Professional (1319); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
 
Event Description
It was reported that a heyman follower labeled with ref # (b)(4) was shipped inside of a case labeled ref # (b)(4). There was no patient involvement.
 
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Brand NameBARD HEYMAN FOLLOWERS COUDE TIP, COMPLETE SET 10-24 FR., STERILE
Type of DeviceHEYMAN 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 Key8231523
MDR Text Key132577706
Report Number1018233-2019-00185
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 05/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number021300
Device Catalogue Number021300
Device Lot NumberMCCU1530
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2018
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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