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

Catalog Number 4253266-02

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

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

Event Date 04/23/2014

Event Type  malfunction  

Event Description

As reported by the user facility: customer verbalized "nurse was called down to the ct room to insert ian introcan and did not know where the needle box was to throw away the needle.After inserting the needle she placed it on the table, dressed the site and picked up the needle, the safety clip was not fully engaged and she got stuck." reference mfr report # 9610825-2014-00161.

• 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 (Section G): B. BRAUN MEDICAL, INC.; 901 marcon blvd.; allentown PA 18109 934
• Manufacturer Contact: 901 marcon blvd.; allentown, PA 18109-9341
• MDR Report Key: 3856300
• MDR Text Key: 20013027
• Report Number: 2523676-2014-00161
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2014,05/06/2014

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: 10/01/2018
• Device Catalogue Number: 4253266-02
• Device Lot Number: 3K08258393
• 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: 05/08/2014
• Distributor Facility Aware Date: 05/06/2014
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1