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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 HEYMAN FOLLOWER COMPLETE SET (10-24FR.)

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C.R. BARD, INC. (COVINGTON) -1018233 BARD HEYMAN FOLLOWERS COUDE TIP, COMPLETE SET 10-24 FR., STERILE HEYMAN FOLLOWER COMPLETE SET (10-24FR.) Back to Search Results
Model Number 021300
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem 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 customer received only a 24fr. When the item should have included 7 additional sizes in the set of 8. Per additional information, it was noted that the packaging did not appear to be for a set of 8.
 
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Brand NameBARD HEYMAN FOLLOWERS COUDE TIP, COMPLETE SET 10-24 FR., STERILE
Type of DeviceHEYMAN FOLLOWER COMPLETE SET (10-24FR.)
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 Key7664286
MDR Text Key113569469
Report Number1018233-2018-02614
Device Sequence Number1
Product Code FBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number021300
Device Catalogue Number021300
Device Lot NumberMCAR3177
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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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