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

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Needle Stick/Puncture (2462); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).The actual device was not available for eval.Without the actual sample, a thorough investigation could not be performed and no specific conclusion can be drawn.Per the event description from the facility, the reported event occurred when the nurse "laid used needle on bed" and placed needle in sharps opening "with needle end pointing towards her palm, and safety clip dislodged or moved to the side".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.The batch mfg record was reviewed and there were no such defect encountered during in-process inspection and at final control inspection.The process cards showed no abnormalities.A historical review of the complaint database identified no adverse trends for product code 4252543-02 or the involved lot.If the sample and/or additional pertinent 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 D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 3896982
• MDR Text Key: 4546470
• Report Number: 9610825-2014-00217
• 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: 06/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1