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

Catalog Number 4252543-02

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 05/12/2014

Event Type  malfunction  

Event Description

As reported by the user facility: customer reports: nurse had successful attempt to start iv.Safety clip did deploy.While cleaning up, had a needle stick.No sample saved.Mfr - 9610825-2014-00277.

• 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: 3952671
• MDR Text Key: 4613479
• Report Number: 2523676-2014-00277
• 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: 07/17/2014,07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4252543-02
• 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: 07/17/2014
• Distributor Facility Aware Date: 07/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1