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

Model Number	4251622-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As per medwatch number: mw0513190000-2022-8006.Description: a nurse was attempting to insert an iv catheter.She was able to successfully insert the catheter with positive blood return visualized.However, when she was withdrawing the metal guidewire, it detached from the plastic hub in her fingers.Approximately 1/2 inch of the guidewire was visible, and she was able to grab the wire and withdraw it from the patient's arm without injury.
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).No sample was provided for evaluation.The manufacturer evaluated their production processes and were unable to identify a process that would create this defect.The reported defect was unable to be confirmed.The actual defective device is a valuable tool in investigating the cause of this incident.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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One sample was provided for further evaluation.The sample was visually evaluated, and the cannula was observed to be detached from the cannula hub.The glue level on the sample were inspected under 20x magnification and presence of glue was observed on complaint sample.Glue residue was also observed on cannula surface.While an exact cause could not be determined, the cannula is 100% cannula strength tested.When subjected to this strength test, a cannula sample found below the strength specification indicates cannula detachment was found and it would be immediately bent and then scrapped by operator.The manufacturer evaluated their production processes and were unable to identify any defects.A review of the device history record was performed and there was no defect 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: 15401169
• Report Number: 9610825-2022-00368
• Device Sequence Number: 6179005
• Product Code: FOZ
• UDI-Device Identifier: 04046964826023
• UDI-Public: (01)04046964826023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2023

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: 12/01/2022
• Device Model Number: 4251622-02
• Device Catalogue Number: 4251622-02
• Device Lot Number: 17N13G8239
• 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: 08/29/2022
• Supplement Date Received by Manufacturer: 08/29/2022; 08/29/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/30/2022; 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2017
• 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 Age: 72 YR
• Patient Sex: Unknown
• Patient Weight: 58 KG
• Patient Race: Asian