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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 Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2023
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 returned to the manufacturer for evaluation.
 
Event Description
Customer reported leaking at y-site hub connection with needle-free connector and chemo leaked on patient.No other information was provided.
 
Event Description
Customer reported leaking at y-site hub connection with needle-free connector and chemo leaked on patient.No other information was provided.Additional information received: treatment provided with hazardous drug/chemo exposure, some patients required de-access and re-access with port needle.Chemo/hazardous drug exposures.No visible damage reported.Hazardous drug/chemotherapy infusions and port accesses in blood draw areas.The procedure was completed as planned.But created hazardous drug/chemo exposure to patient, staff, and home health workers.
 
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.
 
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.
 
Event Description
It was reported port needles were removed from main blood draw for testing/investigation by the customer on 08/25/2023.Needles from lot asgxfc062 were deemed faulty.There were no visible cracks in the hub of the port needle.No visible damage reported.
 
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.Based on a review of this information, the following was concluded: the complaint of a crack in the y-site was confirmed.The returned sample was found to exhibit the same features as a known issue, and the root cause was found to be within the scope of that known issue.This complaint will be recorded for future trending and monitoring purposes.
 
Event Description
It was reported port needles were removed from main blood draw for testing/investigation by the customer on (b)(6) 2023.Needles from lot asgxfc062 were deemed faulty.There were no visible cracks in the hub of the port needle.No visible damage reported.
 
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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 84116
Manufacturer Contact
kayla bevins
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key17795457
MDR Text Key324017672
Report Number3006260740-2023-04232
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup,Followup
Report Date 12/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2023
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 NumberASGXFC062
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2023
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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