MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCANS 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).No sample has been returned for investigation.The batch record could not be reviewed since the lot number is not known.Without the actual sample or lot number, a thorough investigation can not be performed.All available information has been forwarded to the actual manufacturer.If the sample or lot number and/or additional pertinent information becomes available, a follow up report will be filed.While no specific conclusions can be made regarding the cause of the event, it should be noted that the introcan safety is designed to reduce the risk of needle stick injuries.Cdc guidelines and/or facility protocols should always be followed.Sharps should be disposed of immediately into an appropriate sharps container.

• Brand Name: INTROCANS 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: 3838059
• MDR Text Key: 21310787
• Report Number: 9610825-2014-00136
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 04/19/2014
• 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