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

Catalog Number	4252519-02
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: brief inquiry description bumps/protrusions on introcan catheter cannula detailed inquiry description received notice from a customer of oms that they have seen multiple introcan 22gauge catheters with white bumps/protrusions on the cannula making it impossible to insert into patients.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Four (4) photos were submitted to the manufacturer for evaluation.Through visual examination of the photos, a white contaminant on the capillary surface was observed.The origin of the contaminant could not be carried out; however, based on a previous investigation, the white material is likely excess silicone.The sample within the photos are not within specification; the reported defect is confirmed.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.This product is assembled on automated assembly machines equipped with 100% vision inspection system and test stations.Reviewed the assembly machine, there is siliconization station where oil is applied on the product and cannula blow out station to blow out excess silicone.Reviewing the process cards, weekly machine cleaning had been performed according to schedule.The process card recorded machine downtime had occurred at the siliconization station due to excess silicone oil observed on the product.The gripper and silicone oil tank were subsequently cleaned to address the issue.No containment actions were documented following this incident.The absence of containment actions following the downtime indicates a communication gap during assembly.Corrective actions include enhancing the procedure of flushing method at the siliconization station, and conduct training to production personnel on issuance of quality information for any non-conformance triggered during machine troubleshooting/abnormality related to quality issue.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.

• 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 strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22667370
• Report Number: 9610825-2025-00448
• Device Sequence Number: 3825221
• Product Code: FOZ
• UDI-Device Identifier: 04046963165949
• UDI-Public: (01)04046963165949(11)241120(17)291101(10)24M20G8921
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220626
• 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): 09/11/2025

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: 4252519-02
• Device Lot Number: 24M20G8921
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2024
• 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