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 Patient Involvement (2645)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).All available information was forwarded to the actual manufacturer, bbraun (b)(4) and their investigation is on going at this time.A follow up report will be provided when the investigation results become available.Per the event description provided by the reporter, the "nurse was called down to the ct room to insert an introcan and did not know where the needle box was to throw away the needle.After inserting the needle she placed it on the table." it should be noted that the introcan safety is designed to reduce the risk of needle stick injuries.However, cdc guidelines and/or facility protocols should always be followed.Sharps should be disposed of immediately into an appropriate sharps container.

• 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, safety officer ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 3856238
• MDR Text Key: 4618427
• Report Number: 9610825-2014-00161
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1