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

Model Number	4252560-02
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: it was reported that the safety mechanism failed to 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).While no sample was available, two (2) photos were provided for evaluation.Through visual inspection of the photos, it was noted that flashback of blood can be seen in the flashback chamber, while the safety clip position was observed to be in the middle of the cannula and not covering the cannula tip.It is observed that the safety clip has been turned and the clip long arm is not positioned at the bevel eye direction (original position).Unfortunately, the actual malfunction of the safety clip was unable to be identified from the picture.Moreover, the actual condition of the complaint sample (cannula surface condition, crimp length, clip condition, bevel condition or any damages) also cannot be identified from the picture.The actual defective device is a valuable tool in investigating the cause of this incident.Review of the device history record (dhr) for the reported batch number noted no defects encountered during in process and final control inspection.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, 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: 15652248
• Report Number: 9610825-2022-00424
• Device Sequence Number: 2428456
• Product Code: FOZ
• UDI-Device Identifier: 04046963165901
• UDI-Public: (01)04046963165901
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K020785
• 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): 02/11/2023

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: 4252560-02
• Device Catalogue Number: 4252560-02
• Device Lot Number: 22A25G8921
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 02/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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