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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. SAFESTEP; NON-CORING (HUBER) NEEDLE

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BARD ACCESS SYSTEMS, INC. SAFESTEP; NON-CORING (HUBER) NEEDLE 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
SAFESTEP
Type of Device
NON-CORING (HUBER) NEEDLE
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
MDR Report Key10349668
MDR Text Key201376713
Report NumberMW5095815
Device Sequence Number19
Product Code PTI
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 No Information
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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