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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. BARD POWERPORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. BARD POWERPORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Device Problems Leak/Splash (1354); Material Deformation (2976); Material Twisted/Bent (2981)
Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Chemical Exposure (2570)
Event Date 05/15/2020
Event Type  Injury  
Event Description
Surgery, infection, pain; i had a bard powerport implanted into (b)(6) 2020 and the line was curled inside my chest and had a shaving at end per medical records.By (b)(6) 2020 it had failed in my chest and allowed chemicals into my chest cavity.Removed and a new port put in (b)(6) 2020, some infection post op, never stopped itching as of today (b)(6) 2020 when again during a high dose potassium infusion, it failed and spilled the potassium directly into chest, still currently in my chest but will ensure i get possession of device post op.This makes 2 failed bard powerport in 7 months in one patient both in same fashion.These are going to kill someone if they have not already.Fda safety report id# (b)(4).
 
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Brand Name
BARD POWERPORT
Type of Device
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC.
MDR Report Key10559747
MDR Text Key207920965
Report NumberMW5096754
Device Sequence Number1
Product Code LJT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 09/16/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age41 YR
Patient Weight118
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