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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL FRANCE SURECAN SAFETY II SET, ADMINISTRATION, INTRA Back to Search Results
Model Number 4447006-02
Device Problem Fail-Safe Problem (2936)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as event two of 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 Description
As reported by user facility: event 2: 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.
 
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Brand NameSURECAN SAFETY II
Type of DeviceSET, ADMINISTRATION, INTRA
Manufacturer (Section D)
B. BRAUN MEDICAL FRANCE
30 avenue des temps modernes
chasseneuil-du-poitou vienne 86360
FR 86360
MDR Report Key7522498
MDR Text Key108620599
Report Number2532083-2018-00005
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4447006-02
Device Catalogue Number4447006-02
Device Lot Number17L17G8661
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/11/2018
Distributor Facility Aware Date04/26/2018
Device Age18 MO
Event Location Hospital
Date Report to Manufacturer06/11/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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