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

Catalog Number 4251628-03

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

As reported by the use facility (translation of use facility information by bbm sales organization in (b)(6)): the safety clip was not placed in the hub correctly.Mfr - 9610825-2014-00066.

• 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
• Manufacturer (Section G): B. BRAUN MEDICAL, INC.; 901 marcon blvd.; allentown PA 18109 934
• Manufacturer Contact: 901 marcon blvd.; allentown, PA 18109-9341
• MDR Report Key: 3808527
• MDR Text Key: 4384777
• Report Number: 2523676-2014-00066
• Device Sequence Number: 1
• Product Code: FOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 03/19/2014,10/15/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Catalogue Number: 4251628-03
• Device Lot Number: 2L25258315
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2014
• Distributor Facility Aware Date: 03/14/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1