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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Fluid/Blood Leak (1250)
Patient Problem Chemical Exposure (2570)
Event Date 11/15/2023
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 device has not been returned to the manufacturer for evaluation.
 
Event Description
It was reported by customer there was a leak at the luerlock connector level.A chemotherapy infusion was in progress, gemcitabine, no other drugs were infusing.The nurse tried to change the glow plug, but the flow continued thereafter.The team therefore had to manage a spill of chemotherapy drug on the patient and the needle had to be changed.Fortunately, no impact on the patient's skin.Needle containing chemotherapy created a spill of chemo on the user.No consequences for the user.
 
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 leak at the luer could not be confirmed.One 20g powerloc max infusion set w/ y-site was returned for evaluation.A gross visual inspection of the returned unit found no damage or defects to the components.The unit was leak tested by flushing water through each of the luer ports using a luer lok syringe.During testing no leaks were observed.The safety mechanism of the unit was then deactivated and the unit leak tested under pressurization.No leaks were observed.Based on the available evidence, the reported defect could not be confirmed.H3 other text : evaluation findings are in section h11.
 
Event Description
It was reported by customer there was a leak at the luerlock connector level.A chemotherapy infusion was in progress, gemcitabine, no other drugs were infusing.The nurse tried to change the glow plug, but the flow continued thereafter.The team therefore had to manage a spill of chemotherapy drug on the patient and the needle had to be changed.Fortunately, no impact on the patient's skin.Needle containing chemotherapy created a spill of chemo on the user.No consequences for the user.
 
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Brand Name
POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN
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 UT 84116
Manufacturer Contact
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key18387808
MDR Text Key331494693
Report Number3006260740-2023-05859
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741047374
UDI-Public(01)00801741047374
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K153440
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 Received12/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0132075
Device Lot NumberASGXFC036
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2022
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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