MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INTROCAN SAFETY®; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	4253566-01
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the event description: a nurse was punctured herself while disposing of the needle, after the safety device had already triggered but not properly.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).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.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).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.Correction: d1 brand name, d2 type of device.Additional information: d9 device returned to manufacturer.Samples for evaluation: received one (1) used cannula hub and five (5) unused and in original packaging of introcan safety-w pur 20g, 1.1x32mm-eu for lot number 24c15g8316 and material # 4253566-01.Visual inspection: 1 piece cannula hub: observed the safety clip was not engaged onto the cannula tip.The safety clip was dislodged from the cannula.No damages on both external and internal side of clip hole.Clip travel scratch lines was observed on cannula surface until cannula tip area, indicating that the safety clip did travel until the cannula tip.No dented or excess metal nodes observed on cannula surface.The cannula outer diameter was measured and found to be within the specification.Simulation: the returned 1 used cannula hub was manually assembled with a fresh catheter hub for clip verification during cannula withdrawal.Results: from the simulation, the safety clip of the returned sample was able to engage successfully and completely cover the cannula tip.Clip functional test: the returned 5 pieces in original packaging were subjected to safety clip function.Results: from the simulation, the safety clip of the returned sample was able to engage successfully and completely cover the cannula tip.Reference to the instruction for use (ifu): under application section, withdraw needle straight back with a controlled and continuous motion (minimize rotation of needle).Metal safety shield will automatically attach to needle tip as needle tip exits catheter hub.Conclusion: no defect was observed on the clip functional test on the returned samples.No abnormality was observed.Complaint is not confirmed.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: 20788189
• Report Number: 9610825-2024-00853
• Device Sequence Number: 20806901
• Product Code: FOZ
• UDI-Device Identifier: 04046963318253
• UDI-Public: (01)04046963318253(11)240315(17)290301(10)24C15G8316
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4253566-01
• Device Lot Number: 24C15G8316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female