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

Model Number	4447007-02
Medical Device Problem Codes	Fluid/Blood Leak (1250); Protective Measures Problem (3015)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2020
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 on medwatch mw5095237: safety device on huber needle did not stay engaged on needle tip, which caused a needle stick when placing the device in the sharps container.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Based on the data from the investigation we are unable to determine the root cause of the concern.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
• MDR Report Key: 10408763
• Report Number: 9612452-2020-00031
• Device Sequence Number: 2391759
• Product Code: PTI
• UDI-Device Identifier: 04046955156283
• UDI-Public: (01)04046955156283
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: 11/30/2022
• Device Model Number: 4447007-02
• Device Catalogue Number: 4447007-02
• Device Lot Number: 17N31G8670
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1