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

Catalog Number	4252511-02
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 by the user facility: details of complaint (reported issue): "blood leaking where catheter attaches to hub.Defective iv catheter - iv catheter was inserted into vein - immediate flashback confirming position of catheter in vein however blood began leaking where catheter connects with hub causing inability to obtain bloodwork and use catheter for iv.Resulted in loss of iv for an infant with very few sites who was requiring immediate bloodwork." incident date unknown.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Evidence at disposal: no samples returned and no meaningful photos provided for a proper investigation.Device history record (dhr): reviewed the dhr for the complaint batch 24m14g8261 and no abnormality was observed during in-process and at final control inspection.Conclusion: as no sample was received, further investigation was not possible.Based on the batch records, no abnormality was observed during the manufacturing process, thus complaint is 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.
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 sample was subjected to a leakage test; a leak was observed at the capillary near the catheter hub horn area.The sample was inspected under a keyence microscope and a v-shape cut was observed where the leak occurred.This cut is most likely due to reinsertion of the cannula bevel.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.Based on the investigation, leakage was observed on the returned sample.This defect is due to cannula reinsertion and the cause is due to incorrect handling.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: 22888500
• Report Number: 9610825-2025-00497
• Device Sequence Number: 20049675
• Product Code: FOZ
• UDI-Device Identifier: 04046963318161
• UDI-Public: (01)04046963318161(11)241114(17)291101(10)24M14G8261
• 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): 12/03/2025

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: 4252511-02
• Device Lot Number: 24M14G8261
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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