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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 STRAIGHT TIP COMPLETE SET 10-24 FR., STERILE HEYMAN COMPLETE KIT

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C.R. BARD, INC. (COVINGTON) -1018233 BARD HEYMAN FOLLOWERS STRAIGHT TIP COMPLETE SET 10-24 FR., STERILE HEYMAN COMPLETE KIT Back to Search Results
Model Number 021100
Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems No Patient Involvement (2645); 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.
 
Event Description
It was reported that the customer received an incomplete set. Reportedly only the 10fr, 12fr and 24fr were received.
 
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Brand NameBARD HEYMAN FOLLOWERS STRAIGHT TIP COMPLETE SET 10-24 FR., STERILE
Type of DeviceHEYMAN COMPLETE KIT
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 Key8920613
MDR Text Key155495865
Report Number1018233-2019-04939
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 distributor,other,user facili
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number021100
Device Catalogue Number021100
Device Lot NumberMCDS4846
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2019
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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