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

Catalog Number	4251601-04
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event description: a peripheral puncture is performed with a 24 catheter on a patient who does not observe a return through the chamber but through the walls of the same.It is verified and a dysfunctional catheter is removed and it is verified where it is observed to be broken.No patient complications were reported as a result of this event.
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.Complaint analysis: the situation described a peripheral puncture is performed with a 24 catheter on a patient who does not observe a return through the chamber but through the walls of the same.It is verified and a dysfunctional catheter is removed and it is verified where it is observed to be broken.Reference to the instruction for use (ifu): - there is the possibility that the catheter could be cut off as communicated in ifu: warning section stated: - after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off, leading to catheter embolism.Device history record (dhr): reviewed the dhr for the complaint batch 24d01g8921/4251601-04 introcan safety pur 24g, 0.7x19mm-sa and no abnormality was observed during in-process and at final control inspection.Evidence at disposal: no sample received and no photos available for a proper evaluation.Complaint has been added into the statistic for trend analysis.Should sample is received, this notification will be reopened for re-evaluation.Reviewed assembly process: this product is assembled on automated assembly machines equipped with 100% vision system and test stations.The in-line test equipment is subject to frequent calibration and regular verification related to its proper function.Herewith potential malfunctions of the systems would be detected in time and would be mitigated immediately.The assembly process cards was reviewed and no abnormality was observed for the complaint batch.Manufacturing control: besides the in-line test equippment, samples are subjected to in-process and final control qc inspection based on random samples basis.Herewith a systematic product defect would be detected.Qc performs inspection based on the test specification.- specification for capillary surface: no damages such as split, kinks, bumps or scratches are accepted - specification for capillary tip: no damages on capillary tip whereby no cracks, notches or similar defects can be observed and free of plastic chips - there shall be no damages on the overall product condition.The complaint batch passed all the above tests and showed no abnormality.Conclusion: as no sample was received, further investigation was not possible.Complaint is not confirmed.This complaint has been added into the statistic for trend analysis.Should we received the sample, this notification will be reopened for re-evaluation.

• 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: 20907445
• Report Number: 9610825-2024-00904
• Device Sequence Number: 4223204
• Product Code: FOZ
• UDI-Device Identifier: 04046963166274
• UDI-Public: (01)04046963166274(11)240401(17)290401(10)24D01G8921
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 01/03/2025

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 Catalogue Number: 4251601-04
• Device Lot Number: 24D01G8921
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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