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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO SYSTEM; SENSICA TEMPERATURE CABLE

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C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO SYSTEM; SENSICA TEMPERATURE CABLE Back to Search Results
Model Number SCCS1002
Device Problem Fitting Problem (2183)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/19/2022
Event Type  malfunction  
Event Description
It was reported that the temperature cable was too easy to knock out of the temperature module in the sensica device.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the temperature cable was too easy to knock out of the temperature module in the sensica device.
 
Manufacturer Narrative
Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
 
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Brand Name
SENSICA UO SYSTEM
Type of Device
SENSICA TEMPERATURE CABLE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13514887
MDR Text Key285806279
Report Number1018233-2022-00551
Device Sequence Number1
Product Code EXS
UDI-Device Identifier00801741215773
UDI-Public00801741215773
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,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/29/2022
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 Health Professional
Device Model NumberSCCS1002
Device Catalogue NumberSBTC1005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2022
Initial Date FDA Received02/11/2022
Supplement Dates Manufacturer Received07/29/2022
Supplement Dates FDA Received08/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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