MAUDE Adverse Event Report: INTROCAN SAFETY® 3; CATHETER,INTRAVASCULAR

Model Number	4251130-02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun (b)(4) ag internal report (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.If additional pertinent information becomes available a follow-up report will be filed.
Event or Problem Description
As reported by the user facticity: customer just converted to introcan safety 3.Nurse placed a 20g in patient.When threading, started to do a push/pull technique, as is custom with their previous device.Bbraun educator showed that she should hold the hub with left hand and remove the stylet straight out with right hand.Bbraun educator immediately noticed a slight blood leak from hub.By the time the extension set was placed there was a small amount of blood coming out of the hub.Extension set was placed without difficulty and the catheter functioned correctly.

• Brand Name: INTROCAN SAFETY® 3
• Common Device Name: CATHETER,INTRAVASCULAR
• MDR Report Key: 12363625
• Report Number: 9610825-2021-00331
• Device Sequence Number: 14446548
• Product Code: FOZ
• UDI-Device Identifier: 04046964014055
• UDI-Public: (01)04046964014055
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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: 4251130-02
• Device Catalogue Number: 4251130-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2021
• Initial Report FDA Received Date: 08/24/2021
• 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: Initial
• Patient Sequence Number: 1