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

Model Number	4252520-02
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report has been identified as b.Braun medical, inc.Internal report (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.
Event or Problem Description
As reported by the user facility: customer was using 4252520-02 introcan safety catheters.Upon drawing the stylet out of the catheter, the needle was exposed, the safety clip did not function.
Additional Manufacturer Narrative
Thie report has been identified as b.Braun medical, inc.Internal report (b)(4).No sample received and no picture provided for evaluation.Reviewed the device history record for batch number 21h25g8245 and there were no defect encountered during in process and final control inspection as no sample was received, further evaluation was not possible.The complaint batch shows no abnormality.Should sample is received, we will reopen this notification for re-evalaution.Meanwhile, complaint is added into the statistic for trend analysis of this product line.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: CATHETER,INTRAVASCULAR
• 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: 14406969
• Report Number: 9610825-2022-00161
• Device Sequence Number: 5539370
• Product Code: FOZ
• UDI-Device Identifier: 04046963318178
• UDI-Public: (01)04046963318178
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 05/24/2023

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 Expiration Date: 08/01/2026
• Device Model Number: 4252520-02
• Device Catalogue Number: 4252520-02
• Device Lot Number: 21H25G8245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown