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

Catalog Number UNK INTROCAN 20G

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2014

Event Type  malfunction  

Event Description

As reported by the user facility: introcan safety, unknown lot number.Event description: "after starting the iv, she placed the needle portion of iv catheter in 4x4's, and when she picked up the 4x4's that contained the remnants of the iv catheter, she felt something sharp go through her glove." "needle stick happened on (b)(6) 2014.She reports that she started the iv on the patient with a #20g x 1" braun introcan safety device." no sample.Ref mfr report 9610825-2014-00151.

• 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: 3841296
• MDR Text Key: 4660671
• Report Number: 2523676-2014-00151
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/06/2014,04/25/2014

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: UNK INTROCAN 20G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2014
• Distributor Facility Aware Date: 04/25/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1