MAUDE Adverse Event Report: NIPRO (THAILAND) CORP., LTD. NIPRO SAFETOUCH II AVF NEEDLE

Model Number FS+152530BC

Device Problem Break (1069)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

On 6/22/2017: corrected manufacturer report number to 8041145-2017-00007.Device not returned to manufacturer.

Event Description

Patient was set up to start dialysis, treatment was initiated, then the patient care technician noticed air entering the bloodlines and stopped treatment.When removing the avf needle from the patient's graft, the needle/cannula remained inside of the patient's graft.The patient was sent to the emergency room for intervention.Machine used during treatment was the 2008t fresenius dialysis machine.No further information was provided.On 6/12/2017: nurse advised that the patient returned the same day ((b)(6) 2017) to complete the dialysis treatment.No further information was provided.

• Brand Name: NIPRO SAFETOUCH II AVF NEEDLE
• Type of Device: AVF NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP., LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand, 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP., LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand, 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami 33172 ; 3055997174
• MDR Report Key: 6660047
• MDR Text Key: 78238157
• Report Number: 8041145-2017-00007
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/21/2017,06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: FS+152530BC
• Device Lot Number: 16C16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2017
• Distributor Facility Aware Date: 06/05/2017
• Device Age: 15 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/22/2017
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2016
• 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: 90 YR
• Patient Weight: 41