MAUDE Adverse Event Report: MARVAO MEDICAL NEXSITE STEPPED TIP; HEMODIALYSIS CATHETER

Catalog Number NEXHD1555501

Device Problem Contamination (1120)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812)

Event Date 03/22/2016

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation because the device has been disposed; therefore an analysis of the complaint device could not be completed.A review of the manufacturing documentation confirmed that the lot met the specification requirements.The review found no deviations or non-conformances that would have contributed to the reported complaint.Taking into consideration the evaluation conducted and the details of the complaint, this investigation was assigned the most probable root cause of an anticipated procedural complication.A complaint with a most probable root cause classification of an anticipated procedural complication indicates that a device related root cause does not apply and the complaint is due to a known effect of the procedure.

Event Description

Study (b)(6): the nexsite device was successfully placed on (b)(6) 2016 in the right femoral vein.This (b)(6) old female had no issues until (b)(6) 2016 when rn found yellow exudate at catheter exit site while changing dressing.Patient had no complaints of fever or chills, no abnormal vital signs.Patient denied drainage at exit site previous to rn assessment.Access running well.Exit site culture taken on (b)(6) 2016.Staph epidermidis positive culture result on (b)(6) 2016.Patient started on vanco 1000mg iv qhd per sensitivity report and sent to rac for nexsite removal.Patient seen at rac on (b)(6) 2016.Per rac report, purulent drainage noted at exit site as well as abscess.Catheter removed.New right femoral cannon catheter was placed.Patient remains pc dependent as no other options for avg/avf or hero.There were no blood cultures drawn as assessment benign with exception of exit site exudate.Patient has not been hospitalized recently, nor has she had any positive blood cultures.Last culture drawn in center (b)(6) 2015 which was negative for growth.

• Brand Name: NEXSITE STEPPED TIP
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre,; gmit, dublin road,; galway, ; EI
• Manufacturer Contact: fiona geraghty ; innovation in business centre; gmit, dublin road,; galway, ; EI ; 91759301
• MDR Report Key: 5619119
• MDR Text Key: 43992191
• Report Number: 3008110587-2016-00016
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 05391525640105
• UDI-Public: (01)05391525640105(17)161001(10)42457
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/10/2016
• Device Catalogue Number: NEXHD1555501
• Device Lot Number: 42457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2016
• Date Device Manufactured: 10/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 54