MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INTROCAN SAFETY®; INTRODUCER, CATHETER

Model Number	4251300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
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.Device history record (dhr): reviewed the device history record for batch number 23k12g8393 and there were no defect encountered during in process and final control inspection.Evidence at disposal: no sample received but received pictures of x-ray imaging with lateral view of wrist showing a radiopaque linear foreign body indicated as the broken fragment of a catheter.Complaint analysis: the situation reported when a nurse was trying to channel the patient, part of the catheter remains inside the skin, being impossible to remove.Review the instruction for use (ifu): as communicated in the ifu : warning section stated:- · do not re-use.Re-use of single-use devices creates a potential risk for patient or user.It may lead to contamination and/or impairment of functional capability.Contamination and/or limited functionality of the device may lead to injury, illness or death of the patient.· in the case of an unsuccessful iv catheter placement attempt, remove the needle first, then remove the catheter from patient and discard both.· never reinsert the needle inside the catheter once the needle has been partially or completely withdrawn as it may pierce and/or sever the catheter.· extreme care should be taken not to damage, pierce, cut and sever the catheter.Therefore, do not bend the catheter and/or needle during insertion, advancement, or removal of the needle.· do not use scissors or sharp instruments at or near the insertion site.Reviewed assembly process: this product is assembled on automated assembly machines equipped with 100% vision system and test stations.Parts found with defects will be detected and rejected by machines automatically.The assembly process cards for the complaint batch was reviewed and no abnormality was observed.Manufacturing control: besides the in-line test machines, products are subjected to in-process quality controls and final controls inspection based on random samples basis.Herewith a systematic product defect would be detected.The complaint batch shows no abnormality.Conclusion: as no sample was received, further evaluation was not possible.The complaint batch show no abnormality during the manufacturing process.Complaint is not confirmed.
Event or Problem Description
According to the customer: "it is reported by the night shift nursing service, he mentions that when trying to channel the patient, part of the catheter remains inside the skin, being impossible to remove.Currently the patient presents cellulite data with evidence of subcutaneous tissue device.When the oncology service came to verify the information, the nurse said that he was taken to a surgery to remove the part of the device that remained inside.".

• Brand Name: INTROCAN SAFETY®
• Common Device Name: INTRODUCER, 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: 21291202
• Report Number: 9610825-2025-00032
• Device Sequence Number: 18119892
• Product Code: DYB
• UDI-Device Identifier: 04046964399275
• UDI-Public: (01)04046964399275(11)230912(17)280901(10)23K12G8393
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2025

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 Model Number: 4251300
• Device Lot Number: 23K12G8393
• 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: 01/07/2025
• Initial Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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: Male