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

Catalog Number	4251601-02
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Vasculitis (2004)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016018 b.Braun medical inc.(bbmi) (importer) is submitting the report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun medical internal report number (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 or Problem Description
As reported by the user facility: event 2: 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.
Additional Manufacturer Narrative
Exemption number e2016018 event 2: b.Braun medical inc.(bbmi) (importer) is submitting the report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun medical internal report number (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®
• Common Device Name: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun str.1; melsungen, 34212 ; GM 34212
• MDR Report Key: 6287650
• Report Number: 9610825-2017-00011
• Device Sequence Number: 16276773
• Product Code: DYB
• UDI-Device Identifier: 04046963166274
• UDI-Public: (01)04046963166274(17)210601(10)16F01G8318
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K021094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2017
• Report Date (Section F): 02/28/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 4251601-02
• Device Lot Number: 16F01G8318
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/16/2017
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2017
• Supplement Report FDA Received Date: 02/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/28/2017