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

Model Number 4252586-02

Device Problem Break (1069)

Patient Problems Needle Stick/Puncture (2462); Foreign Body In Patient (2687)

Event Date 02/10/2022

Event Type  malfunction  

Manufacturer Narrative

The report has been identified as b.Braun medical, inc.Internal report (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.

Event Description

As reported by the user facility: introcan catheter cannula separated.Customer experienced an issue with a retained portion of the catheter in a patient.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.The actual defective device is a valuable tool in investigating the cause of this incident.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INTROCAN SAFETY®
• Type of Device: CATHETER,INTRAVASCULAR
• 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 ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 13693958
• MDR Text Key: 286767183
• Report Number: 9610825-2022-00062
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046963318215
• UDI-Public: (01)04046963318215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4252586-02
• Device Catalogue Number: 4252586-02
• Device Lot Number: 21B17G8271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• 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
• Patient Outcome(s): Required Intervention