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

Model Number	4252535-02
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, 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: safety feature on needles does not work properly.
Additional Manufacturer Narrative
This 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: safety feature on needles does not work properly.
Additional Manufacturer Narrative
Thie report has been identified as b.Braun medical, inc.Internal report (b)(4).The evaluation is complete and the finding were reported under report number 2523676-2022-00257.Please note: this report is being resubmitted.The mfr report number (9610825-2022-00054) that was originally submitted on 25feb2022 was incorrect.The correct report number is 2523676-2022-00257.
Event or Problem Description
As reported by the user facility: safety feature on needles does not work properly.Please note: this report is being resubmitted.The mfr report number (9610825-2022-00054) that was originally submitted on 25feb2022 was incorrect.The correct report number is 2523676-2022-00257.
Event or Problem Description
As reported by the user facility: safety feature on needles does not work properly.Please note: this report is being resubmitted.The mfr report number (9610825-2022-00054) that was originally submitted on 25feb2022 was incorrect.The correct report number is 2523676-2022-00257.
Additional Manufacturer Narrative
Thie 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.Please note: this report is being resubmitted.The mfr report number (9610825-2022-00054) that was originally submitted on 25feb2022 was incorrect.The correct report number is 2523676-2022-00257.

• 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: 13599955
• Report Number: 9610825-2022-00054
• Device Sequence Number: 12205498
• Product Code: FOZ
• UDI-Device Identifier: 04046963165925
• UDI-Public: (01)04046963165925
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 06/29/2022

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: 4252535-02
• Device Catalogue Number: 4252535-02
• 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: 02/08/2022
• Supplement Date Received by Manufacturer: 02/08/2022; 02/08/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 06/22/2022; 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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