MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY; I.V. SAFETY CATHETER

Catalog Number 4251644-02

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Date 02/17/2014

Event Type  malfunction  

Event Description

As reported by the user facility: ref # (b)(4), lot # unk, 1 item, occurred (b)(6) 2014: reports successful start of iv and cleaned up in a pile and clip became disengaged, and nurse was stuck.Ref: mfr #9610825-2014-00074.

• Brand Name: INTROCAN SAFETY
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen 3421 2; GM 34212
• MDR Report Key: 3733714
• MDR Text Key: 4271859
• Report Number: 2523676-2014-00074
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2014,03/18/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 4251644-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2014
• Distributor Facility Aware Date: 03/18/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1