MAUDE Adverse Event Report: B. BRAUN MEDICAL INDUSTRIES INTROCAN SAFETY®; CATHETER,INTRAVASCULAR

Model Number 4251652-02

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Type  malfunction  

Event Description

As reported by the user facility: employee injury last night.Rn was changing out a 20 gauge iv catheter that was leaking around the hub, cath started separating around the hub.Blood exposure to the eye.

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report (b)(4): the complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).There was no device or sample returned.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.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).There was no device or sample returned.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.Note: this is being resubmitted out of an abundance of caution as the acknowledgements were not documented in our records prior to original submitter leaving the company. original mdr follow-up submitted on 17jun2022.

Event Description

As reported by the user facility: employee injury last night.Rn was changing out a 20 gauge iv catheter that was leaking around the hub, cath started separating around the hub.Blood exposure to the eye.

• Brand Name: INTROCAN SAFETY®
• Type of Device: CATHETER,INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INDUSTRIES; bayan lepas fiz, phase 2; bayan baru penan, 11900 ; MY 11900
• 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: 14218623
• MDR Text Key: 290163765
• Report Number: 9610825-2022-00138
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046963185206
• UDI-Public: (01)04046963185206
• 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,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4251652-02
• Device Catalogue Number: 4251652-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1