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

Model Number	4251652-02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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.
Additional 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 or Problem 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®
• Common Device Name: 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
• Report Number: 9610825-2022-00138
• Device Sequence Number: 5359284
• Product Code: FOZ
• UDI-Device Identifier: 04046963185206
• UDI-Public: (01)04046963185206
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K020785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 04/06/2022; 04/06/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 06/17/2022; 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown