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

Catalog Number 4251652-02

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

Patient Problem No Information (3190)

Event Date 09/24/2014

Event Type  malfunction  

Event Description

As reported by the user facility: started iv in er in post mi pt, known iv drug user, iv started successfully; when discarding needle, the safety clip slide dislodged off to side-dirty needle stick.Nurse is receiving post stick treatment per facility protocol.

Manufacturer Narrative

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

• 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: 4180742
• MDR Text Key: 5096872
• Report Number: 9610825-2014-00355
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/29/2014,09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: 4251652-02
• Device Lot Number: 4B22258383
• 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: 09/29/2014
• Distributor Facility Aware Date: 09/24/2014
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2014
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1