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

Model Number	4447006-02
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported by the user facility: the surecan needle did not lock in place resulting in needlestick for rn.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.

• 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 86360 ; FR 86360
• 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: 12963139
• Report Number: 9612452-2021-00057
• Device Sequence Number: 1791167
• Product Code: PTI
• UDI-Device Identifier: 04046955156276
• UDI-Public: (01)04046955156276
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 11/26/2022
• Device Model Number: 4447006-02
• Device Catalogue Number: 4447006-02
• Device Lot Number: 17N26G8670
• 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: 11/11/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 06/08/2022
• 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