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

Catalog Number 4251628-02

Device Problem Positioning Problem (3009)

Patient Problem Infiltration into Tissue (1931)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: "three iv sticks on one patient woman).Iv was started uneventfully.After fluids were started and only less than 100cc was infused the iv infiltrated and you could see the skin swell up." the iv needed to be restarted.Normal saline was being infused.Sample was not saved.

Manufacturer Narrative

(b)(4).Multiple unsuccessful 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.A historical review of the complaint database identified no adverse trends for product code 4251628-02 or lot number involved.If a sample and/or additional pertinent information becomes available, a follow up 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, 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: 5833099
• MDR Text Key: 50905706
• Report Number: 9610825-2016-00514
• 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,Followup
• Report Date: 10/10/2016,07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: 4251628-02
• Device Lot Number: 15M13G8302
• 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: 10/10/2016
• Distributor Facility Aware Date: 07/08/2016
• Device Age: 9 MO
• Event Location: Other
• Date Report to Manufacturer: 10/10/2016
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2015
• 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
• Patient Outcome(s): Other