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

Model Number NEXHD1552801

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Nausea (1970); Vomiting (2144)

Event Date 05/11/2016

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

(b)(4): the nexsite device was successfully placed in this patient on (b)(6) 2016.On (b)(6) 2016, a moderate infection was reported.The patient complained of being sick and her abdominal pain while attending dialysis.She spat up saliva with brown streaks.Blood cultures were taken that day and the patient attended the emergency department where she was diagnosed with chronic abdominal pain with episodes of vomiting.The subject returned to dialysis on (b)(6) 2016 with a temperature of 99.2f.Catheter care was performed and there were no reported signs of infection.Blood was obtained that day for blood cultures as well due to the patient's continuous nausea and vomiting.These bloods showed coagulase (b)(6).The device was removed on (b)(6) 2016 and vancomycin was given.The event resolved on the same date.

Event Description

Conclusion of the cec (clinical events committee) following adjudication of the adverse event: likely blood culture contaminant.Bloodstream infection not indicated.

• Brand Name: NEXSITE HD STEPPED TIP
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre; gmit, dublin road; galway, H91 D CH9; EI H91 DCH9
• Manufacturer Contact: fiona geraghty ; innovation in business centre,; gmit, dublin road; galway, galway H91 D-CH 9 ; EI H91 DCH 9 ; 91759301
• MDR Report Key: 5690606
• MDR Text Key: 46257627
• Report Number: 3008110587-2016-00023
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 05391525640020
• UDI-Public: (01)05391525640020(17)161101(10)42550
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/11/2016
• Device Model Number: NEXHD1552801
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 42550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2018
• Date Device Manufactured: 12/07/2015
• 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: 40 YR
• Patient Weight: 92