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

Catalog Number 4251628-03

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Needle Stick/Puncture (2462); No Information (3190)

Event Date 10/10/2014

Event Type  malfunction  

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): there was a leakage from the capillary while our customer took away needle from the catheter-hub.So customer did astriction to stop leakage of blood.Then, the needle stuck hand of customer.(this patient has not infection disease).Additional information: when nurse punctured and removed the inner needle, she was strongly the astriction in a hurry again because it had been full of reverse blood from the hub.At that time, attached a finger at the hub stuck the inner needle to burst through catheter.She pull out the inner needle, but she didn't move or remove it in the catheter.Customer indicated that there was a hole near the catheter and hub.

Manufacturer Narrative

(b)(4).The device is currently shipping from (b)(6) to the manufacturer for investigation.A follow up report will be provided after the inspection results become available.The batch record could not be reviewed since the lot number is not known.

• 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: 4290158
• MDR Text Key: 5084021
• Report Number: 9610825-2014-00417
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/18/2014,10/23/2014

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 Catalogue Number: 4251628-03
• 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: 10/27/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2014
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: No
• 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