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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION SET 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION SET 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problems Fluid/Blood Leak (1250); Defective Component (2292)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/24/2024
Event Type  Injury  
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 manufacturer has received the sample and will evaluate.Results are expected soon.
 
Event Description
It was reported by customer that the product is cracked.It appears to be the extension tubing itself which would be different than the statlock devices which would go over the tubing and hub.Leaking stat-lock arterial line device.Newly inserted arterial line stat-lock device noted to have blood backing up and leaking on pillow.Upon switching to new line, noted crack in tubing where blood was leaking from.Product issue with cracking causing blood to back up into tubing, inaccurate blood pressure, switched to new stat-lock with no issues.It was reported this occurred with two devices.One device was used on a patient and one was not used on a patient.This report addresses the device that was used on a patient.
 
Event Description
It was reported by customer that the product is cracked.It appears to be the extension tubing itself which would be different than the statlock devices which would go over the tubing and hub.Leaking stat-lock arterial line device.Newly inserted arterial line stat-lock device noted to have blood backing up and leaking on pillow.Upon switching to new line, noted crack in tubing where blood was leaking from.Product issue with cracking causing blood to back up into tubing, inaccurate blood pressure, switched to new stat-lock with no issues.It was reported this occurred with two devices.One device was used on a patient and one was not used on a patient.This report addresses the device that was used on a patient.
 
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 LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION SET 25 BOX
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
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key18822017
MDR Text Key336739019
Report Number3006260740-2024-00877
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberART0420
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/04/2024
Was Device Evaluated by Manufacturer? No
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) Required Intervention;
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