MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL 18G X 1 SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 18G X 1 ¼

Device Problem Backflow (1064)

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

Event Date 03/17/2020

Event Type  malfunction  

Event Description

As rn was attempting to obtain iv access, she saw flashback in the chamber, however it was not contained, and it continued to fill the entire "safety" chamber.When the safety device was detached from the catheter, blood also flowed out of the catheter.With this particular iv catheter, it should not backflow until it has been flushed at least once.The iv catheter remained in place and functioned without incidence.Smiths medical 18g x 1 ¼ safety iv catheter.Lot number 3911027.

• Brand Name: SMITHS MEDICAL 18G X 1 SAFETY IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11982305
• MDR Text Key: 255633355
• Report Number: 11982305
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 18G X 1 ¼
• Device Lot Number: 3911027
• 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: 06/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9125 DA