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

Catalog Number	4252500-02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported from medsun uf/ importer report # (b)(4): describe the event or problem: while placing iv, catheter was not kinked when they inserted it, however when they went to flush it, saline/ blood sprayed back from the site.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample was submitted to the manufacturer for evaluation; the cannula hub and protective cap were not returned for evaluation.Through visual examination, no damages or abnormalities were observed on the capillary surface and at the luer lock area.The returned sample was connected with a syringe and flushed with red dye solution; no leakage was observed from the entire catheter hub.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or nonconformances were noted during the in process or final product inspection.This product is assembled on automated assembly machines equipped with 100% vision system on capillary leakage at leakage test station.The defective parts will be detected and automatically rejected by the machine.The process cards of the complaint batch show no abnormalities.Based on the investigation, the reported defect could not be observed nor replicated.The sample is within specification; the complaint is considered not confirmed.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: 21641339
• Report Number: 9610825-2025-00125
• Device Sequence Number: 7662253
• Product Code: FOZ
• UDI-Device Identifier: 04046963165963
• UDI-Public: (01)04046963165963(11)240726(17)290701(10)24G26G8302
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K020785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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: 4252500-02
• Device Lot Number: 24G26G8302
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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 Age: 1 MO
• Patient Sex: Unknown