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

Catalog Number 4251601-02

Device Problem Positioning Problem (3009)

Patient Problem Phlebitis (2004)

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: event 5: customer reports, "has had patients over the last 2 months who have had phlebitis at insertion site.All have diagnosis of chronic regional pain syndrome.All complained of burning when drug administered, phlebitis noted at site anywhere from 5 hours to 3 days of dwell time.Phlebitis symptoms anything from small red swollen at insertion site to red streak up vein.Reports all were treated with and responded well to amoxicillin, no other intervention required.All are attending ketamine clinic for pain, all receiving drug, all have same site prep and dressing.All iv's started by same nurse.Reports most of these patients did not have histories of skin reactions to different products or many allergies.Customer reports 10 events; however, it is unknown if the units were material number (b)(4)/batch number 16c16g8392 or material number (b)(4)/batch number 16f01g8318, so the complaint units were split evenly between two pirs: (b)(4): material number (b)(4)/batch number 16c16g8392: 5 complaint units, (b)(4): material number (b)(4)/batch number 16f01g8318: 5 complaint units.

Manufacturer Narrative

(b)(4).Multiple unsuccessful attempts were made to obtain a sample and additional information.Although a sample was not received, all available information was forwarded to the manufacturer.Based on the manufacturer's statement, no root cause could be determined without the actual sample to evaluate.Therefore, the reported complaint was not confirmed.Process evaluation for the reported article number 4251601-02 and batch number 16f01g8318 was performed to the extent possible.Records show that from 2013 to january 2017, the sterilization process, biological indicator and cytotoxicity study, all appear to support the conclusion that the manufacturing process of the device does not contribute to skin reactions/inflammation.However, if the sample and/or any additional pertinent information becomes available, the complaint will be re-opened and a thorough investigation will be performed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• 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: 6287656
• MDR Text Key: 66146243
• Report Number: 9610825-2017-00014
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 04046963166274
• UDI-Public: (01)04046963166274(17)210601(10)16F01G8318
• 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: 02/28/2017,01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 4251601-02
• Device Lot Number: 16F01G8318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2017
• Distributor Facility Aware Date: 01/16/2017
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2017
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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