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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: SENTRINEX 3D PORT
• Common Device Name: STAND, INFUSION
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11422484
• Report Number: 3006260740-2021-00631
• Device Sequence Number: 17157139
• Product Code: FOX
• UDI-Device Identifier: 00801741117039
• UDI-Public: (01)00801741117039
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SXSPT01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention