SMITHS MEDICAL CENTRAL VENOUS CATHETERSDELTEC LOGICATH CONVENTIONAL
Received Sep 13, 2019 · Event occurred May 1, 2019
Report 3012307300-2019-04974 · MDR key 9037810
Device
Generic name
Central Venous Catheter Dressing Change Kit
Manufacturer
Smiths Medical Asd, Inc.Catalog number
MXA231X20X16V
Lot number
3337605C
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- Fever
- Patient Problem/Medical Problem
- Fever
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
CORRECTED INFORMATION: THE FILE WAS INADVERTENTLY MARKED REPORTABLE. THE EVENT REPORTED UNDER MFR WAS DETERMINED TO BE NOT REPORTABLE AND NO FURTHER REPORTS WILL BE FILED USING THIS FILE NUMBER. THE DEVICE IS NOT APPROVED FOR DISTRIBUTION IN THE U.S. AND IS NOT SIMILAR TO A PRODUCT APPROVED FOR DISTRIBUTION IN THE U.S.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: ADVERSE EVENT OR PRODUCT PROBLEM, EVENT, PMA/510K AND TYPE OF REPORTABLE EVENT.
Description of Event or Problem
INFORMATION WAS RECEIVED STATING DEVICES WERE SEALED PRIOR TO OPENING. CUSTOMER STATED IT IS UNCLEAR WHETHER STERILE FIELD WAS BROKEN WHILE DEVICE WAS IN USE, OR IF PROTOCOLS FOR A STERILE FIELD WERE IN PLACE. THE SYMPTOMS OF THE PATIENT DISAPPEARED FOLLOWING EXTUBATION, AND THE PATIENT IS RECOVERING WELL. BECAUSE THE DEVICES WERE EXTUBATED, THIS WILL NOW BE REPORTED AS AN AVERSE EVENT.
Description of Event or Problem
INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL CENTRAL VENOUS CATHETER WAS IN USE, PATIENT HAD SYMPTOMS SUCH AS HIGH FEVER AND WOUND SUPPURATION. UPON REMOVAL OF THE DEVICE, THE SYMPTOMS HAD DISAPPEARED. NO FURTHER ADVERSE EFFECTS HAVE BEEN REPORTED.