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

Catalog Number	4254562-02
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: details of complaint (reported issue): "anesthesia went to start an iv on a patient, the needle portion went thru the side of the iv catheter.I have placed both the iv catheter and needle in a red sharps container.The needle is protected in sharps contained and the iv catheter has patient's blood in it.Please be careful when opening the red sharps box to view item." level of harm: no apparent harm - reached patient/person, inconvenient impact of incident: unsuccessful 1st attempt iv start.Second attempt was required and was successful.
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).A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or nonconformances were noted during the in process or final product inspection.This product line is assembled on an automatic assembly machine equipped with 100% vision system and test stations.Along the machines, there is 100% inspection on the condition of the catheter tip.Parts found out of the inspection on the condition of the catheter tip.Parts found out of the inspection criteria will be detected and be rejected by machine.The process cards shows no abnormalities for the complaint batch.No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be 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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample was submitted to the manufacturer for evaluation.Through visual examination, the capillary was observed to be have been pierced by the cannula near the catheter hub horn.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or nonconformance's were noted during the in process or final product inspection.This product line is assembled on an automatic assembly machine equipped with 100% vision system and test stations.Along the machines, there is 100% inspection on the condition of the catheter tip.Parts found out of the inspection on the condition of the catheter tip.Parts found out of the inspection criteria will be detected and be rejected by machine.The process cards shows no abnormalities for the complaint batch.Based on the investigation, the defect is more than likely a result of an application error and not a manufacturing error.The defect is most likely due to reinsertion of the cannula.Based on this information, the 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: 19928030
• Report Number: 9610825-2024-00636
• Device Sequence Number: 8083190
• Product Code: FOZ
• UDI-Device Identifier: 04046963318369
• UDI-Public: (01)04046963318369
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2024

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: 4254562-02
• Device Lot Number: 23M27G8263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/17/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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