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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWER LOC MAX; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS, INC. POWER LOC MAX; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number REF 0724086
Device Problems Backflow (1064); Crack (1135); Leak/Splash (1354)
Patient Problem Fever (1858)
Event Date 02/15/2017
Event Type  malfunction  
Event Description
A 20 g, 3/4" power port needle tubing spontaneously cracked near the end of the port infusion tubing.The crack is right under the hub area where the power port needle tubing extension attaches to the main tubing connection.It caused blood to backflow and leak out of the crack.Rn in room when happened patient line clamped then re-accessed within 10 minutes not open exposed long.Had been fevering before and after, blood cultures drawn, negative to date since event.Had been accessed for 2 days.Patient continuously infusing chemotherapy first 24 hours then tpn/lipids and medications.Clamped line, re-accessed patient was calm, sleeping all day, sick so not fighting lines, pulling at port etc.Manufacturer response for power injectable infusion set for implanted ports, power loc max (per site reporter): sent email to local rep last month.
 
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Brand Name
POWER LOC MAX
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 n 5600 west
salt lake city UT 84116
MDR Report Key7238409
MDR Text Key98933886
Report Number7238409
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberREF 0724086
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/22/2017
Device Age2 DY
Event Location Hospital
Date Report to Manufacturer02/22/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
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