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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POWERLOC MAX; SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS, INC. BARD POWERLOC MAX; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Nonstandard Device (1420); Material Split, Cut or Torn (4008)
Patient Problems Swelling (2091); No Code Available (3191)
Event Date 07/20/2020
Event Type  Injury  
Event Description
Patient reported that huber powerloc needle line is splitting.She switched to safestep, which was also splitting.Then, a recall on these products was released.The patient developed swelling and a lump at her port site.She then developed a fever and was hospitalized.Her port is being removed and a midline iv will be placed so that she can receive iv antibiotics.More information to follow after she is released from the hospital and we can get a full timeline of events and lot numbers.Huber powerloc 22gx1 (lot # ascyf018, ascyf019, asczf026, asdrf047, asdrf048, asdrf049, asdrf050); huber safestep 22x0.5 (lot # ascyf013, ascyf014, asczf029, ascvf034,ascvf035, ascvf038, ascvf042); huber safestep 22x1 (lot # asdnf034, asdnf049, asdnf055, asdpf015, asdpf017, asdpf021, asdpf024, asdpf025, asdpf026, asdqf017, asdrf066, asduf120, asdvf004, asdvf009, asdvf013, asdvf016, asdvf025).Fda safety report id# (b)(4).
 
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Brand Name
BARD POWERLOC MAX
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
MDR Report Key10349668
MDR Text Key201376713
Report NumberMW5095815
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/28/2020
24 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9   10   11   12   13   14   15   16   17   18   19   20   21   22   23   24  
1 Patient was Involved in the Event
Date FDA Received07/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age34 YR
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