MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY IV CATHETER 22GA; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 4252520-020

Device Problems Break (1069); Device Damaged Prior to Use (2284)

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

Event Date 05/07/2023

Event Type  malfunction  

Event Description

At least 3 b.Braun introcan safety iv catheters size 22 g 1.75" were found broken in the packaging with packaging intact.Catheters were retrieved from box in this condition.Lot # 0061699798 iv catheters used for vascular access.Reference report: mw5117889, mw5117890.

• Brand Name: INTROCAN SAFETY IV CATHETER 22GA
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 17009948
• MDR Text Key: 316152109
• Report Number: MW5117890
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4252520-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2023
• Patient Sequence Number: 1