MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL CENTRAL VENOUS CATHETERSDELTEC LOGICATH CONVENTIONAL; CENTRAL VENOUS CATHETER DRESSING CHANGE KIT

Catalog Number MXA231X20X16V

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Patient Problem/Medical Problem (2688)

Event Date 05/01/2019

Event Type  malfunction  

Event Description

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.

Event Description

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.

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.

• Brand Name: SMITHS MEDICAL CENTRAL VENOUS CATHETERSDELTEC LOGICATH CONVENTIONAL
• Type of Device: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9037828
• MDR Text Key: 159049525
• Report Number: 3012307300-2019-04972
• Device Sequence Number: 1
• Product Code: PEZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: MXA231X20X16V
• Device Lot Number: 3337605C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1