MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER

Model Number FD+142530BC-CAP

Device Problems Dull, Blunt (2407); Structural Problem (2506)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 10/02/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pt 1: have had issues with nipro needles, i've sent emails to the appropriate staff who are looking into this due to other hhd nurses having same problems with the nipro needles.Basically the blunt needles are too sharp and have been causing damage to patient's fistulas.I have gotten approval from the physician at my facility to use medisystems avf needle again.On 10/12/2015: according to the fa, the surgical intervention happened a few months ago, and after the fistula was then able to be used again.(details were not provided by the field administrator our clinical specialist has attempted again on 10/13/2015 to obtain further information but the field administrator was not available).

Manufacturer Narrative

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

Event Description

Pt 1: have had issues with nipro needles, i've sent emails to the appropriate staff who are looking into this due to other hhd nurses having same problems with the nipro needles.Basically the blunt needles are too sharp and have been causing damage to patient's fistulas.I have gotten approval from the physician at my facility to use medisystems avf needle again.10/12/2015: according to the fa, the surgical intervention happened a few months ago, and after the fistula was then able to be used again.(details were not provided by the field administrator our clinical specialist has attempted again on 10/13/15 to obtain further information but the field administrator was not available).

• Brand Name: NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
• Type of Device: BIOHOLE 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: 5162203
• MDR Text Key: 28814180
• Report Number: 8041145-2015-00076
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100520
• 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: 10/20/2015,11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FD+142530BC-CAP
• 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: 10/20/2015
• Distributor Facility Aware Date: 10/05/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/20/2015
• 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