MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INTROCAN SAFETY®; I.V. SAFETY CATHETER

Model Number	4253540-01
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
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.Corrected information d4 primary unique udi number evidence at disposal: no sample received and no picture available for a proper analysis.Device history record (dhr): reviewed the device history record for batch number 24b06g8361 and there were no defect encountered during in process and final control inspection.Reviewed assembly process: this product is assembled on automated assembly machines equipped with 100% vision system and test stations.The vision system checks the clip presence and clip condition.Defective parts which failed the vision system checking will be detected and be rejected automatically by machines.The in-line test equipment is also subjected to frequent calibration and regular verification related to its proper function.Herewith potential malfunctions of the systems would be detected immediately and would be mitigated immediately.The process cards for the complaint batch was reviewed and no abnormality observed.Manufacturing control: besides the in-line test equipment, products are subjected to functional inspection by in-process qc and final control qc based on random samples basis.The complaint batch passed the clip function test.Conclusion: as no sample and no picture available, further investigation was not possible.The complaint batch show no abnormality during the manufacturing process.Complaint is therefore not confirmed.
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.
Event or Problem Description
According to the complaint: " i wanted to infuse the patient, i had put on my gloves, i had not taken a box on my trolley, i left towards the care station with my 3 catheters in my hand and secured to put them in a needle box.The safety of one of the catheters was removed and i pricked myself with the catheter with which i had tried to infuse the patient." immediate actions: hand washing, 5-minute dakin bath and analysis done by nurse hygienist.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: I.V. SAFETY CATHETER
• 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: 20415755
• Report Number: 9610825-2024-00753
• Device Sequence Number: 8390038
• Product Code: FOZ
• UDI-Device Identifier: 04046963317638
• UDI-Public: (01)04046963317638(11)240206(17)290201(10)24B06G8361
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/31/2024

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: 4253540-01
• Device Lot Number: 24B06G8361
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• 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
• Patient Sex: Unknown