MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY ® 2; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	4242004-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: brief inquiry description hole in ivc and shearing the sheath detailed inquiry description there appears to be a hole in the cathlons next to the plastic hub also several of these are shearing the sheath on insertion.
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) photo and one (1) video were provided to the manufacturer for evaluation.The photo was of the peel packaging for the product.Through visual examination of the video, an introcan safety 2 22g was observed inside a patient vein and blood is seen flowing out from the capillary tube near the horn.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 system and test stations.Along the machine, there is capillary leakage test station and when subjecting to this leakage test, a sample that exceeds the leakage pressure specification indicates leakage was found and it would be automatically rejected and removed at the reject part station.The process cards of the complaint batch show no abnormalities.Based on the investigation of the video, the reported issue of catheter leakage was observed.However, without the actual sample, further investigation is not possible to determine an exact root cause.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).H6 updated with corrected information/codes: health effect - clinical code (e): 2462 - needle stick/puncture health effect - impact code (f): 4613 - non-serious injury/illness/impairement.4604 - delay to treatment/ therapy.

• Brand Name: INTROCAN SAFETY ® 2
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem PA 18018
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 23100447
• Report Number: 9610825-2025-00521
• Device Sequence Number: 15783081
• Product Code: FOZ
• UDI-Device Identifier: 04046955745869
• UDI-Public: (01)04046955745869(11)241219(17)291201(10)24N19G8271
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K220756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2025

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: 4242004-02
• Device Lot Number: 24N19G8271
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/07/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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