MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; INTRODUCER, CATHETER

Catalog Number	4251611-02
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by user facility: brief inquiry description: failed safety shield on 24g is.Detailed inquiry description: safety shield did not deploy.No injury reported.
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) unused sample was submitted to the manufacturer for evaluation.Through visual examination, it was observed that the safety clip at the middle of the cannula was not engaged on the cannula tip.The safety clip was inspected under a microscope under 20x magnification and no damages on the clip arm and back wall as well as the clip hole were observed.Clip travel scratched lines were observed along the cannula surface.No dents or excess metal nodes were observed on the cannula surface.Scratch marks were observed at the inner catheter hub luer surface made by the safety clip.The cannula outer diameter, near crimp area, middle of the cannula and near cannula hub were measured and the measurements were within specification.The crimp width and crimp length of the complaint cannula sample were measured and were found to be within specification.A simulation was carried out by manually assembling the returned cannula with a returned catheter hub for verifying the clip function during cannula withdrawal.From the simulation, the safety clip of the returned sample was able to engage successfully and completely cover the cannula tip.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, the safety clip was able to engage successfully and covered the cannula tip.The defect encountered by the user is mostly likely due to an application error.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: INTRODUCER, CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 19220033
• Report Number: 9610825-2024-00340
• Device Sequence Number: 8194264
• Product Code: DYB
• UDI-Device Identifier: 04046963318123
• UDI-Public: (01)04046963318123
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021094
• 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
• Report Date (Section B): 05/30/2024

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: 4251611-02
• Device Lot Number: 23H21G8266
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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