MAUDE Adverse Event Report: MEDISYSTEMS CORP. MEDISYSTEMS HEMODIALYSIS FISTULA NEEDLE SET

Model Number	S9-7005MG
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
After the insertion of needle into the dialysis graft, it was noted a red substance at the distal end (away from the patient) of tghe medisystem hemodialysis fistula needle set.

• Brand Name: MEDISYSTEMS HEMODIALYSIS FISTULA NEEDLE SET
• Common Device Name: MEDISYSTEMS HEMODIALYSIS FISTULA NEEDLE SET
• Manufacturer (Section D): MEDISYSTEMS CORP.; lawrence MA 01843
• MDR Report Key: 6839186
• Report Number: MW5071921
• Device Sequence Number: 19022858
• Product Code: KMK
• UDI-Device Identifier: 00842289100978
• UDI-Public: (01)00842289100978
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: S9-7005MG
• Device Catalogue Number: S9-7005MG
• Device Lot Number: 161122F7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1