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

Model Number N/A

Device Problem Device Operational Issue (2914)

Patient Problems Chest Pain (1776); Dyspnea (1816); Phlebitis (2004)

Event Date 12/13/2015

Event Type  Injury  

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, lot number and/or additional pertinent information becomes available, a follow up report will be filed.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): phlebitis at introduction site.The hospital reported problems with introcan safety v on a (b)(6), patient initials (b)(6), implant date: (b)(6) 2015.The device was used for infusion treatment in a female patient which underwent a surgical procedure on knee prostheses on (b)(6) 2015.Since that moment till the moment in which the incident occured, physicians had been performing an infusion therapy with that device.On (b)(6) 2015 physicians noticed phlebitis at introduction site of cannula needle in right wrist (at first treated with wraps of ichthyol).On (b)(6) 2015, they noticed occurence of chest pain, dyspnea, sweating, strong pain at phlebitis site and hyperpyrexia.It was performed internist and infectious disease consulting.It was performed a computerized axial tomography on forearm with contrast medium on (b)(6) 2015 which showed a thrombophlebitis with presence of inflammatory tissue starting from dorsal area of wrist and of hand and extension intraluminal to cephalic vein.Consequence of the incident: patient hospitalization or extension of it.The device involved was 1 but not available.At discharge ((b)(6) 2015), the event was in process of recovery with antibiotic therapy prescribed by infection disease doctor.

• Brand Name: INTROCAN® SAFETY
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5700940
• MDR Text Key: 46617215
• Report Number: 9610825-2016-00335
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2016,05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• 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: 06/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2016
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/06/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR