MAUDE Adverse Event Report: B.BRAUN MEDICAL SAS SURECAN SAFETY II; NON-CORING (HUBER) NEEDLE

Model Number	4447010-02
Medical Device Problem Codes	Fail-Safe Problem (2936); Device Handling Problem (3265)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).Event 1: 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 the user facility: event 1.Customer reports that the passive safety shield failed to engage all the way and resulted in a needlestick injury.Customer states it happened twice to two different clinicians (same lot number).
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample returned, no investigation could be done.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: SURECAN SAFETY II
• Common Device Name: NON-CORING (HUBER) NEEDLE
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• Manufacturer (Section G): B. BRAUN MEDICAL FRANCE; 30 avenue des temps modernes; chasseneuil-du-poitou, vienne 86360 ; FR 86360
• Manufacturer Contact: catherine boismenu ; 30 avenue des temps modernes; chasseneuil du poitou,, PA 86360 ; FR 86360 ; 4847197287
• MDR Report Key: 12752368
• Report Number: 9612452-2021-00053
• Device Sequence Number: 16520842
• Product Code: PTI
• UDI-Device Identifier: 04046964858130
• UDI-Public: (01)04046964858130
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K170897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: 12/26/2025
• Device Model Number: 4447010-02
• Device Catalogue Number: 4447010-02
• Device Lot Number: 21A26G8672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown