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

Model Number	4447006-02
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as event one of b.Braun medical inc.(b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: event 1: when the technician was removing the huber needle from the patient, the safety mechanism did not activate.The safety mechanism slides to the bottom of the needle but doesn't engage.No patient injury.
Additional Manufacturer Narrative
This report has been identified as event one of b.Braun inc.Internal report number (b)(4).One used device was received for evaluation.The safety mechanism was tested, and it could be activated without any difficulties.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.A batch record review for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned device met requirements according to specification, and the reported failure could not be reproduced.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: SURECAN SAFETY II
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL FRANCE; 30 avenue des temps modernes; chasseneuil-du-poitou vienne 86360 ; FR 86360
• MDR Report Key: 7522513
• Report Number: 9612452-2018-00025
• Device Sequence Number: 1438475
• Product Code: FPA
• UDI-Device Identifier: 04046955156276
• UDI-Public: (01)04046955156276
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K170897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018
• Report Date (Section F): 06/11/2018

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: 09/17/2022
• Device Model Number: 4447006-02
• Device Catalogue Number: 4447006-02
• Device Lot Number: 17L17G8661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/26/2018
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Date Report Sent to FDA: 06/11/2018