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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 29MM 100BX

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C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 29MM 100BX Back to Search Results
Model Number 39102
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Information (3190)
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 catheter was a size 36mm instead of 29mm.
 
Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.
 
Event Description
It was reported that the catheter was a size 36mm instead of 29mm.
 
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Brand Name
ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 29MM 100BX
Type of Device
MEC
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 Key7000699
MDR Text Key91359643
Report Number1018233-2017-05696
Device Sequence Number1
Product Code NNX
UDI-Device Identifier00801741071287
UDI-Public(01)00801741071287
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number39102
Device Catalogue Number39102
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/18/2017
Initial Date FDA Received11/03/2017
Supplement Dates Manufacturer Received11/06/2017
Supplement Dates FDA Received11/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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