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

Catalog Number 4251628-01

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Needle Stick/Puncture (2462); No Patient Involvement (2645)

Event Date 11/01/2014

Event Type  malfunction  

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): when cleaning under the bed, maintenance worker saw something and went to pick it up - did not realize it was a used needle and received a needlestick injury.No safety clip was present on the cannula and a wrapper was found under the bed also - hospital assuming wrapper is packaging from this sample but unconfirmed that needle is bbraun product.

Manufacturer Narrative

(b)(4).The device is currently shipping from (b)(4) for investigation.A follow up report will be provided after the inspection results become available.We have informed our manufacturer accordingly.Reviewed the device history record and found no defects at in-process inspection and at final control inspection.The process cards show no abnormalities.It should be noted that the introcan safety is designed to reduce the risk of needle stick injuries.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 ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4290148
• MDR Text Key: 5084024
• Report Number: 9610825-2014-00420
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/18/2014,11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• 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: 4251628-01
• Device Lot Number: 4B08258302
• 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: 11/18/2014
• Distributor Facility Aware Date: 11/06/2014
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2014
• Date Manufacturer Received: 11/06/2014
• 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