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

Catalog Number 4251127-02

Device Problem Chemical Problem (2893)

Patient Problem Phlebitis (2004)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has not been received yet and the investigation in on going at this time.A follow up report will be provided when the inspection results become available.

Event Description

As reported by the user facility: customer reports to that chemical phlebitis is occurring.This is occurring with medications such as taxotere, taxol, cistplatin, adromycin.Customer verbalizes that this has been occurring for the past couple of months, and when they use nexiva brand, this does not occur.

Manufacturer Narrative

(b)(4).Result of examination: examination of the infusomat space (isp): the infusomat space (isp) was visually inspected.From outside, signs of usage were visible.Cover caps of the screw domes and the seal under the bottom of the isp were available and undamaged.The isp was delivered together with an inserted iv-line, which had a hole at the set-base safety clamp.Upon switch-on, the isp showed a device alarm, which prevented starting of the device.Disassembly of the pump showed that fluid had ingressed and partially affected the main board, which is the reason for the device alarm shown at start-up.The complaint is considered not justified with regard to the infusomat space.Reason for the fluid ingress is the hole in the iv-line, which was delivered together with the pump.The hole in the iv-line was not caused by a malfunction of the infusomat space (see below).Examination of the attached infusomat space line: together with the above described infusomat space, we received one used infusomat space line, standard without package (the green slide clamp is not closed).The sample was taken to a visual examination: at the green slide clamp we detected a damage at the hook, most likely caused by the door of the isp by improper positioning during closing the door (use error).At the line we detected at the area of the green clamp a crack.We detected no sharp edges at the green slide clamp.Measures of clamp and line were according to specification.The complaint is considered not justified with regard to the infusomat spaceline.Line and slide clamp are in line with specification in terms of measures and form (no sharp edges).Reason for the hole in the infusomat space line is attributed to an improper positioning of the iv-line during door closing (user error).It should be noted that the correct insertion of the disposable line and start of infusion is correctly described in the ifu.

• 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 ; carl-braun-strasse 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5061406
• MDR Text Key: 28435704
• Report Number: 9610825-2015-00452
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2015,10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Catalogue Number: 4251127-02
• Device Lot Number: 15G30G8372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2015
• Distributor Facility Aware Date: 10/01/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2015
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other