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

Model Number 4252527-02 REF

Device Problem Difficult to Flush (1251)

Patient Problem Insufficient Information (4580)

Event Date 06/10/2021

Event Type  malfunction  

Event Description

Iv catheter used to insert 20g into pt's left cephalic vein.Images seen on us were good, iv cath had blood return.Attached tubing to flush and was unable to.Removed the catheter slowly while drawing back , no blood at this time.Attempted to flush after it was out, catheter would not flush.Removed catheter from tubing, which flushed.Attempted to flush catheter again and would not flush.Iv therapy team was able to flush iv only when they applied a lot of force 20 gauge 1 3/4 inch catheter.

• Brand Name: BRAUN INTROCAN SAFETY IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; bethlehem PA
• MDR Report Key: 12032800
• MDR Text Key: 257550544
• Report Number: MW5101990
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/16/2021

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 Model Number: 4252527-02 REF
• Device Lot Number: 20K20G8242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR