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

Model Number	4447000-02
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
Event or Problem Description
As reported by the user facility: "the needle cover would not lock into place resulting in a nurse getting stuck with the needle.".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).We have checked the manufacturing file of batch nr20f09g8670 which complies with our specifications and does not present any discrepancy.Another similar complaint from the same end customer has been reported to us on this batch of (b)(4) released in october 2020.Without the complaint sample for investigation no thorough investigation is possible and we cannot conclude on the real cause of the incident.If new elements become available in the future, we will reopen this complaint.This type of incident is a known risk of the use of needles.The surecan safety ii has a manually activated safety mechanism that is designed to deploy upon needle removal and to shield the tip, to reduce needlestick injuries.Surecan safety ii's features include a green dot, which appears through the clear bottom plate when the safety mechanism is successfully engaged.Reviewed the dhr for the batch no.20f09g8670, no related defect was observed during the in-process and final control inspection.Batch size: (b)(4).Batch released date: 2020-10-16.

• Brand Name: SURECAN SAFETY II
• Common Device Name: NON-CORING (HUBER) NEEDLE
• Manufacturer (Section D): B. BRAUN MEDICAL FRANCE; 30 avenue des temps modernes; chasseneuil-du-poitou, vienne
• Manufacturer (Section G): B. BRAUN MEDICAL FRANCE; 30 avenue des temps modernes; chasseneuil-du-poitou, vienne 86360 ; FR 86360
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 13524706
• Report Number: 9612452-2022-00009
• Device Sequence Number: 5248090
• Product Code: PTI
• UDI-Device Identifier: 04046964857737
• UDI-Public: (01)04046964857737
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 08/03/2022

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: 05/09/2025
• Device Model Number: 4447000-02
• Device Catalogue Number: 4447000-02
• Device Lot Number: 20F09G8670
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown
• Patient Race: Asian