MAUDE Adverse Event Report: SMITH MEDICAL ASD, INC. JELCO PROTECTIV PLUS-W SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number 3696132

Device Problems Fluid/Blood Leak (1250); Flushing Problem (1252)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2019

Event Type  malfunction  

Event Description

Patient required iv access.24 gauge wing tipped catheter used.Iv was inserted, received a flash, advance iv catheter, and unable to flush iv.When pulling back catheter this rn noticed blood squirting out the side of the catheter.Catheter was damaged.This happened twice with two different 24 gauge wing tip catheters.

• Brand Name: JELCO PROTECTIV PLUS-W SAFETY IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITH MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9450290
• MDR Text Key: 170248978
• Report Number: 9450290
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3696132
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 360 DA