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

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).We received one introcan safety pur 20g, 1.1x32mm-eu in original packaging.The received sample was subjected to a visual examination.Damages or mfr faults were not detected.In addition we visually checked the position of the clip at the sample according to test plan.Nominal: both arms of the safety clip must be sitting in the groove of the housing.Actual: mfr faults were not detected.The clip of the sample is sitting in the correct position.Furthermore we tested the safety clip function of the sample according to test plan.Nominal: place and hold the housing firmly on a table, while the other hand is to pull the needle with clip completely out of the housing.The needle clip must be blocked and to test this, push the needle on a stretched rubber glove.The needle tip must not puncture through the glove.Actual: we detected no function faults on the sample.The special feature of a self-activating safety clip that automatically covers the needles sharp bevel was given.The tip of the needle did not puncture through the glove.We detected no inadmissible surface irregularities at the raw cannula which could lead to a malfunction.The received sample does meet our requirements.We have informed our 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.No specific conclusion can be drawn.

• 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, safety officer ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 3721923
• MDR Text Key: 4275862
• Report Number: 9610825-2014-00065
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1