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

Model Number	4447007
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch history review: a batch record review for the reported lot number did not reveal any abnormalities or non-conformances of this nature.No other customer complaints have been reported on this batch of needles.Investigation: 3 unused needles from the same batch were received for evaluation.The safety mechanism was tested, and it could be activated without any difficulties.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.Conclusion: based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned devices met requirements according to specification, and the reported failure could not be reproduced.If additional pertinent information becomes available a follow-up report will be filed.
Event or Problem Description
The nurses of the oncology department have experienced several times, difficulties to release the safety mechanism of the needle during retrieval.This could cause accidental blood exposure.

• Brand Name: SURECAN SAFETY II
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• MDR Report Key: 8613928
• Report Number: 9612452-2019-00073
• Device Sequence Number: 2004093
• Product Code: FPA
• UDI-Device Identifier: 04046955156283
• UDI-Public: (01)04046955156283
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

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: 08/11/2023
• Device Model Number: 4447007
• Device Catalogue Number: 4447007-02
• Device Lot Number: 18K11G8671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1