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

Catalog Number 4252543-02

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

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/06/2014

Event Type  malfunction  

Event Description

As reported by the user facility: event description: facilities mgr reporting needlestick injury to nurse.Reports the following: "nurse attempting to start iv and was unsuccessful noting blown iv.Nurse removed needle and cannula, then slid catheter off needle and set down.Second iv attempt started and successful.Upon clean up of supplies by nurse, she was stuck in her right middle finger by the needle.The safety tip was noted not to be engaged.Nurse sent to lab for testing.

Manufacturer Narrative

(b)(4).All available info was forwarded to the actual mfr, bbraun (b)(4) and their investigation is on going at this time.A follow up report will be submitted when the investigation results become available.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: 4071939
• MDR Text Key: 4897620
• Report Number: 9610825-2014-00314
• 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: 08/25/2014,08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: 4252543-02
• Device Lot Number: 4C29258371
• 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: 08/25/2014
• Distributor Facility Aware Date: 08/12/2014
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2014
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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