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

Catalog Number	4252543-02
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2011009.B.Braun medical inc.Is submitting a single report on behalf of b.Braun melsungen (the manufacturer), and b.Braun medical inc.(the importer).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: customer stated, "metal pulled apart when backing out." limited information provided.No injury.No sample.
Additional Manufacturer Narrative
Exemption number e2011009.B.Braun medical inc.Is submitting a single report on behalf of b.Braun melsungen (the manufacturer), and b.Braun medical inc.(the importer).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.No sample was returned for evaluation; because of this, further investigation of the complaint is not possible and no conclusion could be drawn.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.Device history record (dhr): review of the device history records was performed and no non conformances or deviations were noted in process and final inspection.

• 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: 6140758
• Report Number: 9610825-2016-00835
• Device Sequence Number: 223937
• Product Code: DQR
• UDI-Device Identifier: 04046963185190
• UDI-Public: (01)04046963185190(17)210106(10)16F14G8304
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2016
• Report Date (Section F): 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 4252543-02
• Device Lot Number: 16F14G8304
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/18/2016
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 12/19/2016
• 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: 12/19/2016