MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY® 3; CATHETER,INTRAVASCULAR,THE

Model Number	4251129-02
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
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: reported incident: the safety, although engaged, did not slide all the way down to the end of the needle.Thus leaving the tip of the needle exposed.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used and contaminated sample was provided for further evaluation.The protective cap and capillary hub were not returned for investigation.The manufacturer evaluated their production processes and were unable to identify a process that would create this defect.The returned sample was checked, and no dent mark or abnormality were observed from the cannula surface of all cannula orientation and no damage or deformation observed on safety clip during investigation.Simulation was carried out by manual assembled the returned cannula with catheter hub and withdrawing the returned sample.The safety clip of complaint cannula sample was able to engage successfully and completely cover cannula tip.The reported incident was unable to be confirmed.A review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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® 3
• Common Device Name: CATHETER,INTRAVASCULAR,THE
• 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16544525
• Report Number: 9610825-2023-00088
• Device Sequence Number: 6520977
• Product Code: FOZ
• UDI-Device Identifier: 04046964014031
• UDI-Public: (01)04046964014031
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111236
• 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): 04/20/2023

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 Model Number: 4251129-02
• Device Catalogue Number: 4251129-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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