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

Catalog Number 4251644-01

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Type  malfunction  

Event Description

As reported by the user facility (translation of user facility info by bbm sales organization in (b)(6)): the physician fell and cut his hand with the side of the safety clip.Ref mfr #9610825-2014-00086.

• 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: 3733732
• MDR Text Key: 4309508
• Report Number: 2523676-2014-00086
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2014,03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Catalogue Number: 4251644-01
• Device Lot Number: 3L05258319
• 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: 03/31/2014
• Distributor Facility Aware Date: 03/20/2014
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1