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

Catalog Number 4251601-02

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 12/28/2013

Event Type  malfunction  

Event Description

As reported by the user facility: customer reports two nurses were drawing blood from a baby.The needle was pulled out of the baby and the safety mechanism activated but it did not fully cover the needle.The rn was punctured by a contaminated needle.Ref mfr report 2523676-2014-00195.

• 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
• MDR Report Key: 3841299
• MDR Text Key: 4681759
• Report Number: 2523676-2014-00195
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2014,04/25/2014

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 Catalogue Number: 4251601-02
• Device Lot Number: 3D12258391
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/25/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2014
• Distributor Facility Aware Date: 04/25/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1