MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; CATHETER,INTRAVASCULAR,THE

Model Number 4253523-02

Device Problem Fail-Safe Problem (2936)

Patient Problem Perforation of Vessels (2135)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

As reported by the user facility: "after confirming 24g piv was successfully placed in patient's left ac vessel, i continued to advance catheter off of the needle into the vessel and released the tourniquet.The vessel was occluded and catheter hub was stabilized.When removing the needle from the hub, i met resistance and was unable to successfully disconnect the needle from the hub.Because of this, the catheter was removed from the patient's vessel with the needle still in hub.This caused trauma to my patient's delicate vessels and placed me at an increased risk for a needlestick or blood-borne pathogen exposure.".

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample or photos were submitted to the manufacturer for evaluation.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.If the device does become available, the complaint will be reopened for further evaluation.The complaint is considered not confirmed.

• Brand Name: INTROCAN SAFETY®
• Type of Device: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16930834
• MDR Text Key: 315205942
• Report Number: 9610825-2023-00206
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046963318239
• UDI-Public: (01)04046963318239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

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: 4253523-02
• Device Catalogue Number: 4253523-02
• Device Lot Number: 22C09G8921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1