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

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.

• Brand Name: SENTRINEX 3D PORT
• Type of Device: STAND, INFUSION
• 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 ; 8015950700
• MDR Report Key: 11422484
• MDR Text Key: 241943282
• Report Number: 3006260740-2021-00631
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: SXSPT01
• Device Lot Number: UNKNOWN
• 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 Received: 02/04/2021
• 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