MAUDE Adverse Event Report: B. BRAUN MEDICAL FRANCE SURECAN SAFETY II; SET, ADMINISTRATION, INTRA

Model Number	4447012-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by user facility: event 2: needle broke off and remained in patient's chest/port.

• Brand Name: SURECAN SAFETY II
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL FRANCE; 30 avenue des temps modernes; 86360 ; FR 86360
• MDR Report Key: 8821591
• Report Number: 2532083-2019-00002
• Device Sequence Number: 3205753
• Product Code: PTI
• UDI-Device Identifier: 04046955156320
• UDI-Public: (01)04046955156320
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2019
• Report Date (Section F): 07/24/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: 4447012-02
• Device Catalogue Number: 4447012-02
• Device Lot Number: 17L24G8661
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/26/2019
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 07/24/2019