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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemolysis (1886)

Event Date 02/20/2023

Event Type  malfunction  

Event Description

Email sent to ed pi: "multiple hemolyzed samples.From new iv catheters.".

• Brand Name: INTROCAN SAFETY
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 16635377
• MDR Text Key: 312230753
• Report Number: 16635377
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/22/2023

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2023
• Date Report to Manufacturer: 03/29/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1