MAUDE Adverse Event Report: MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY) MEDISYSTEMS AV FISTULA NEEDLE SET; HEMODIALYSIS FISTULA NEEDLE SET

Model Number D9­2005MGLB

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/14/2015

Event Type  Injury  

Manufacturer Narrative

The event has been attributed to use error.The actual sample used in this event was discarded by the user facility but retraining has been requested on the medisystems product and is scheduled to be delivered by medisystems field clinical support.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

On (b)(6) 2015 at 6:35, the user was removing the patient's needle post treatment without covering the needle.The needle stuck the user's left index finger.User facility policy and cdc recommendations were followed including administration of combivir, an (b)(6) postexposure prophylactic medication.

• Brand Name: MEDISYSTEMS AV FISTULA NEEDLE SET
• Type of Device: HEMODIALYSIS FISTULA NEEDLE SET
• Manufacturer (Section D): MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY); 350 merrimack street; lawrence MA 01843
• Manufacturer (Section G): KAWASUMI LABORATORIES CO,. LTD; 48 mu8, ratchasima chokchai ro; tambon tha ang; amphoe chok chai, nakhon ratchasima 30190 ; TH 30190
• Manufacturer Contact: paula rogalski ; 350 merrimack street; lawrence, MA 01843 ; 9786874700
• MDR Report Key: 5117020
• MDR Text Key: 27218950
• Report Number: 2919260-2015-00004
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: D9­2005MGLB
• Device Catalogue Number: D9­2005MGLB
• Device Lot Number: 150325F3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2015
• 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): Other