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

Catalog Number 4251129-02

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 Type  malfunction  

Manufacturer Narrative

(b)(4).Customer confirmed that the batch number is unknown and sample was discarded.Multiple attempts were made to obtain a sample.No sample was returned for evaluation ; because of this, further investigation of the complaint is not possible and no conclusion could be drawn.Hence, the complaint is assessed to be not judgable.If a sample and/or additional pertinent information becomes available, a follow up will be submitted.

Event Description

As reported by the user facility: customer stated, "she was helping another nurse with an iv insertion.The catheter insertion was not successful, the nurse withdrew the needle and catheter together from the patient and at that point the patient moved causing the helping nurse to be stuck by the contaminated needle.The safety mechanism failed when the catheter was pulled out of the patient.When the needle was pulled back it remained attached to the catheter and did not lock.The nurse starting the iv did not realize this and i didn't either.She was removing the tourniquet from the patients arm with the iv still in her hand and i got stuck with the infected needle." no patient injury reported.No sample available.Sample was discarded in the sharps container.

• Brand Name: INTROCAN SAFETY®
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun str.1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun str.1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; b. braun melsungen ag; carl-braun str. 1; melsungen, 34212 ; GM 34212 ; 661712769
• MDR Report Key: 5726373
• MDR Text Key: 47457134
• Report Number: 9610825-2016-00368
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2016,05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 4251129-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2016
• Distributor Facility Aware Date: 05/25/2016
• Event Location: Home
• Date Report to Manufacturer: 06/15/2016
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1