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

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

Patient Problems Needle Stick/Puncture (2462); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).The actual device has not been received and the investigation is ongoing at this time.A follow up report will be submitted when the investigation results become available.

• 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 Contact: ludwig schuetz ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 3841290
• MDR Text Key: 4681237
• Report Number: 9610825-2014-00202
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1