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

Catalog Number	4254503-02
Medical Device Problem Code	Fail-Safe Problem (2936)
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: event 1: brief inquiry description.Clip did not engage on introcan.Detailed inquiry description: we have had a few issues with the introcan safety iv catheter winged-fep where the safety feature has failed.I have had one nurse that this has happened on 2 occasions, the first one she forgot to get a picture of the needle, but took a picture of the package.The second time it happened, she called me over so i could take a picture of the needle.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Event 1 device history record (dhr): reviewed the dhr for the complaint batch 24c29g8391 and no abnormality observed during in-process and at final control inspection.Picture evaluation: as picture was provided by customer and observed a used cannula with the safety clip located near the cannula hub and did not engage at the cannula tip.The actual condition of the cannula condition, crimp length, clip condition and bevel condition could not be identified through the picture.Visual inspection and clip functional test: the returned sample was visually inspected and was subjected to clip functional test.Result: passed.Reviewed safety clip batch details: the stamping of ipqc data for the clip batches used in the complaint sample showed no deviation and all measurements were within the specification.Conclusion: the returned sample safety clip was able to function as intended and cover the cannula tip.No abnormality observed on the returned sample.The complaint manufacturing batch show no abnormality.Hence, 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.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: CATHETER,INTRAVASCULAR,THE
• 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: 20305565
• Report Number: 9610825-2024-00746
• Device Sequence Number: 15350523
• Product Code: FOZ
• UDI-Device Identifier: 04046963318314
• UDI-Public: (01)04046963318314
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/10/2024

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: 4254503-02
• Device Lot Number: 24C29G8391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2024
• 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