SENTRINEX 3D PORT
Received Mar 5, 2021 · Event occurred Feb 4, 2021
Report 3006260740-2021-00631 · MDR key 11422484
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
SXSPT01
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Foreign Body Reaction
- Foreign Body Reaction
Narrative
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.
Description of Event or Problem
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.