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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK ARTERIAL PLUS CRESCENT TRICOT BND STOPCOCK ALC PREP 500 CS; SET, ADMINISTRATION, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 STATLOCK ARTERIAL PLUS CRESCENT TRICOT BND STOPCOCK ALC PREP 500 CS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Fluid/Blood Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 09/06/2023
Event Type  malfunction  
Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been received by the manufacturer for evaluation.H3 other text : device not returned.
 
Event Description
It was reported by customer that the arterial statlock extension tubing spontaneously breaking.Additional information (b)(6).We have reviewed and in every case, it is the same reported complaint ¿ the extension tubing spontaneously breaks.Since this is an arterial line which is needed to monitor and treat critically ill icu patients, there is a significant bleeding risk to the patient.With these tubing breaks, patients have been found bleeding, had blood loss, delay in treatment due to needing to obtain and replace hemodynamic tubing and/or insert a new arterial line.No additional patient information is available nor relevant for these cases.It was reported this occurred with four devices.This report addresses the first device.
 
Event Description
It was reported by customer that the arterial statlock extension tubing spontaneously breaking.Additional information 9/15 : we have reviewed and in every case, it is the same reported complaint ¿ the extension tubing spontaneously breaks.Since this is an arterial line which is needed to monitor and treat critically ill icu patients, there is a significant bleeding risk to the patient.With these tubing breaks, patients have been found bleeding, had blood loss, delay in treatment due to needing to obtain and replace hemodynamic tubing and/or insert a new arterial line.No additional patient information is available nor relevant for these cases.It was reported this occurred with four devices.This report addresses the first device.
 
Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.
 
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Brand Name
STATLOCK ARTERIAL PLUS CRESCENT TRICOT BND STOPCOCK ALC PREP 500 CS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
DAVOL SURGICAL INNOVATIONS -9616067
ave. roberto fierro #6408
parque industrial aeropuerto
cd. juarez, chih s.a. de c.v. 32690
MX   32690
Manufacturer Contact
becky garcia
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key17799204
MDR Text Key324045916
Report Number3006260740-2023-04253
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberARTNS001
Device Lot NumberJUGZ8651
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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