MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INTROCAN SAFETY® 3; IV CANNULAE,

Model Number 4251131JP

Device Problem Break (1069)

Patient Problem Discomfort (2330)

Event Date 11/06/2023

Event Type  malfunction  

Event Description

As reported by the user facility information by bbm sales organization in japan: according to the complainant the catheter was found to be broken in the patient's arm at the point of puncture.

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.Sample for evaluation: received one (1) part of a broken piece of a used and contaminated with coagulated blood inside the capillary.The catheter hub, cannula hub and protective cap were not returned for investigation.Visual inspection: the return sample#s capillary tear off area exhibits a clear v shape cut from the cannula bevel.The used capillary inner diameter then was measured using pin gauge and the inner diameter is 0.9 millimeters (mm) which is similar with capillary size g18 inner diameter.Conclusion: this defect is not due to manufacturing process but mostly likely due to reinsertion of the cannula.This defect is due to application error.Complaint is not confirmed.

• Brand Name: INTROCAN SAFETY® 3
• Type of Device: IV CANNULAE,
• Manufacturer (Section D): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18369208
• MDR Text Key: 331331937
• Report Number: 9610825-2023-00629
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/20/2023

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 Model Number: 4251131JP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1