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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2023
Event Type  malfunction  
Event Description
It was reported by the customer "i have a port needle with y-site that leaked at the connector y-site.This area has notable white powder on the tubing and connector and is not site where the chartwell pump tubing was connected to." no other information was provided.
 
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 is pending evaluation.Results are expected soon.
 
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 complaint of a leaking y-site was confirmed.The product returned for evaluation was one 19g powerloc infusion set w/y-site.A gross visual inspection of the returned unit found that two injection caps were returned attached to the two luers of the infusion set.The unit was leak tested by flushing water through each of the injection caps using a 12ml luer lok syringe.During testing, no leaks were observed.The same leak test was performed, except with the clamps engaged to simulate pressurization.A leak was then observed between the injection cap and the luer of the y-site.The injection cap was inspected and found to be loosely attached to the luer.The injection cap was tightened and the pressurized leak test performed again.No leaks were observed.Finally the unit was leak tested with and without pressurization by connecting the luer lok syringe directly to the luer of the infusion set and no leaks were observed again.Based on the available evidence, the reported leak was present but was caused by inadequate tightening of the injection cap.
 
Event Description
It was reported by the customer "i have a port needle with y-site that leaked at the connector y-site.This area has notable white powder on the tubing and connector and is not site where the chartwell pump tubing was connected to." no other information was provided.
 
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Brand Name
POWERLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE
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)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer Contact
kayla bevins
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key18412788
MDR Text Key331639311
Report Number3006260740-2023-05908
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741047893
UDI-Public(01)00801741047893
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0671910
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2024
Was Device Evaluated by Manufacturer? Yes
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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