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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SENTRINEX 3D PORT STAND, INFUSION

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C.R. BARD, INC. (BASD) -3006260740 SENTRINEX 3D PORT STAND, INFUSION Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Reaction (1868)
Event Date 02/04/2021
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event Description
It was reported via ms&s "patient/nurse caller with bard port using sentrinex 3d port dressing from hospital (ref# sxspt01, lot# 204006) experienced a local skin reaction she states is from the sentrinex adhesive resulting in serous fluid and some skin coming off where she has had to stop her infusion therapy. Patient has weekly infusions. Patient called her cancer center doctor and dermatologist. Patient has been using sentrinex dressing for three years without an issue and has had two recent skin issues when using the dressing. The lot number provided is the hospital's product stock given to patient. Patient asking if there has been an adhesive change. Patient also asking for port dwell time. " ms&s informed i am not aware of an adhesive change with sentinex. Explained port does not expire once implanted and dwell time is a clinical/medical decision made between patient and healthcare provider. This report addresses the second skin issue the patient experienced.
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Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer Contact
kelsey erickson
605 north 5600 west
salt lake city 84116
MDR Report Key11422484
MDR Text Key241943282
Report Number3006260740-2021-00631
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberSXSPT01
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/05/2021 Patient Sequence Number: 1