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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER LOC MAX; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS POWER LOC MAX; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Break (1069); Material Puncture/Hole (1504)
Patient Problems Exposure to Body Fluids (1745); Fever (1858); Lymphoma (3263)
Event Date 06/19/2019
Event Type  Injury  
Event Description
My daughter has acute lymphoblastic leukemia.She is currently admitted to (b)(6) children's hosp due to fever and multiple viruses.On (b)(6) 2019, my daughter woke up from her nap around 5pm, in a pool of blood, i tore her clothes off to find that her port was broken where the clamp is supposed to close.The nurse had failed to clamp either clamps, leading my daughter to be exposed to bacteria for an undetermined amount of time (possibility of 4 hours).The brand of needle / line was power loc max (.75 inch, 20 gauge needle) and had somehow formed a hole in it.This is not the first time this has happened.In fact.This is the 5th time, with 4 other breakages of the same type happening in (b)(6) of 2018.Each time this happens, my daughter is exposed to harmful, life threatening bacteria.Fda safety report id# (b)(4).
 
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Brand Name
POWER LOC MAX
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
MDR Report Key8731088
MDR Text Key149243705
Report NumberMW5087587
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/24/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age3 YR
Patient Weight13
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