MAUDE Adverse Event Report: NIPRO CORP. NIPRO FISTULA 14G X 1 BE/CL SAFE TOUCHD; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number FS-162530BC

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2022

Event Type  malfunction  

Event Description

A user facility care statt reported to fresenius customer support that they have an issue with these 14g needles.The back clear cap will not come off even after being tightened as on wednesday (b)(6) 2022 causing patient blood to sprout out.Also, product cap has a history of sealing extremely well, at other times being very difficult to remove.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NIPRO FISTULA 14G X 1 BE/CL SAFE TOUCHD
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): NIPRO CORP.
• MDR Report Key: 17488370
• MDR Text Key: 320697728
• Report Number: MW5121069
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2023

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?: No
• Device Catalogue Number: FS-162530BC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1