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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SHERLOCK 3CG TCS STAND; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 SHERLOCK 3CG TCS STAND; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number 9770132
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/22/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been received by the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.Device not returned for evaluation.
 
Event or Problem Description
The customer problem is that the netbook battery is dying too quickly.The device battery dying immediately after being unplugged.
 
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Brand Name
SHERLOCK 3CG TCS STAND
Common Device Name
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key10838156
Report Number3006260740-2020-20531
Device Sequence Number19557009
Product Code LJS
UDI-Device Identifier00801741124365
UDI-Public(01)00801741124365
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K113808
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/26/2020
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
Operator of Device Health Professional
Device Model Number9770132
Device Catalogue Number9770132
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/22/2020
Initial Report FDA Received Date11/13/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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