MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO AVF NEEDLE TULIP

Model Number FT+152530TP

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Skin Irritation (2076); Reaction, Injection Site (2442)

Event Date 09/25/2015

Event Type  Injury  

Manufacturer Narrative

Pending evaluation from factory on retained samples for random lots.Sample not returned.

Event Description

Patient experiencing pain and irritation at needle insertion site on left-arteriovenous-fistula, patient was switched back to the medisystems needles per physician for medical necessity as evidenced by scabbed, reddened areas on left-arteriovenous-fistula ((b)(6) 2015 received fe exception email for pt, per clinic patient do not require f/u since they received exception to switch back to old needle.Exception paperwork (b)(6) 2015.Exception approval (b)(6) 2015.) (b)(6) 2015: according to the field administrator, this has been occurring over time since starting to use the nipro needles, however it became too much for the patient on (b)(6) 2015, the patient was switched back to the medisystems, no medical interventions were necessary, no hospitalizations or injuries per the field administrator.

Manufacturer Narrative

Pending evaluation from factory on retained samples for random lots.11/4/15: manufacturer investigation report on retained representative samples attached.

Event Description

Patient experiencing pain and irritation at needle insertion site on left-arteriovenous-fistula, patient was switched back to the medisystems needles per physician for medical necessity as evidenced by scabbed, reddened areas on left-arteriovenous-fistula ((b)(6) 2015 received fe exception email for pt, per clinic patient do not require f/u since they received exception to switch back to old needle.Exception paperwork (b)(4) 2015.Exception approval (b)(4) 2015.) (b)(6) 2015: according to the field administrator, this has been occurring over time since starting to use the nipro needles, however it became too much for the patient on (b)(6) 2015, the patient was switched back to the medisystems, no medical interventions were necessary, no hospitalizations or injuries per the field administrator.

• Brand Name: NIPRO AVF NEEDLE TULIP
• 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 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 5160194
• MDR Text Key: 28673900
• Report Number: 8041145-2015-00075
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2015,11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FT+152530TP
• Device Lot Number: UNKNOWN
• 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: 10/19/2015
• Distributor Facility Aware Date: 10/05/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/19/2015
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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