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

Catalog Number 4251644-01

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

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

As reported by the user facility ((b)(4)): the nurse was pricked with the needle, the safety device did not work correctly during removal.

Manufacturer Narrative

(b)(4).No sample was returned for investigation.Without the actual sample, a thorough investigation could not be performed.Wa have informed out mfr accordingly.Reviewed the device history record and there were no defect encountered during in-process and final control inspection.Process cards also show no abnormalities.It should be noted that he 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.(b)(4).

• Brand Name: INTROCAN SAFETY
• Type of Device: IV SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen 3421 2; GM 34212
• Manufacturer Contact: ludwig schuets, safety officer ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4617912
• MDR Text Key: 16541005
• Report Number: 9610825-2015-00077
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/16/2015,01/15/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: 4251644-01
• Device Lot Number: 4C02258302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2015
• Distributor Facility Aware Date: 03/10/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2015
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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