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

Model Number 4251644-04

Device Problem Device Handling Problem (3265)

Patient Problem Discomfort (2330)

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(6).A follow-up report will be provided after the examination results are available.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.

Event Description

As reported by the user facility information by bbm sales organization in brazil: " damaged / product" according to the complainant, after therapy, a "burr" on the metal part of the device cut the finger of the device operator.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The following investigations were conducted: the received customer picture is blurred, therefore a clearly deviation of the product is not visible.Just by means of the customer picture the complained deviation and therefore an evaluation of the complaint is not possible by hc-pm complaint processing.Summary and assessment: as no sample and no meaningful picture was provided for investigation a malfunction could not be detected and therefore the complaint is considered as not confirmed.The complaint is only taken to knowledge and filed for statistical purposes.However, if the complaint sample will be provided, the complaint will be re-opened accordingly.The investigation sample(s) is/are not available.Device history record (dhr): reviewed the device history record for batch number 23b08g8316 and there were no defect encountered during in process and final control inspection.Evidence at disposal: no sample was returned for investigation purpose but nonetheless, hc-pm complaint team received a picture from the customer of introcan safety pur 20g, 1.1x32mm-sa.As the received customer picture is blurred, therefore a clear deviation of the product is not visible (see attached customer picture in cc-notification).Complaint is not confirmed.This complaint shall also be taken to the knowledge and filed for statistical purpose.Nevertheless, if the complaint sample is being returned, hence complaint will be re-open and re-investigated accordingly.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.

• Brand Name: INTROCAN SAFETY®
• 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: 18369398
• MDR Text Key: 331315059
• Report Number: 9610825-2023-00616
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4251644-04
• Device Lot Number: 23B08G8316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2023
• 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