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).In a follow up with the facility, the reporter stated that the lot number was unknown and the sample had been discarded.The reporter confirmed that the nurse had "labs done" and was "ok".Without the actual sample or lot number, a thorough investigation could not be performed and no specific conclusion can be drawn.Per the event description, the incident occurred during clean up.It should be noted that the introcan safety is designed to reduce the risk of needle stick injuries.However, (b)(4) guidelines and/or facility protocols should always be followed.Sharps should be disposed of immediately into an appropriate sharps container.All available information has been provided to the actual manufacturer, b braun malaysia for informational purposes.If additional pertinent information becomes available, a follow up report will be submitted.

• 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 34212 ; GM 34212 ; 661712769
• MDR Report Key: 3952627
• MDR Text Key: 4612473
• Report Number: 9610825-2014-00277
• 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
• Remedial Action: Other
• Type of Report: Initial

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?: No
• Device Operator: Other
• Date Manufacturer Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1