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

Model Number	5010024
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch history review: a review of the manufacturing records shows this batch of filters complied with specifications.No other similar complaints were reported to the manufacturer for this lot of vena cava filters, sold since june 2018.Investigation: the device is not available for evaluation.No x-ray pictures were sent for analysis.Conclusion: no thorough investigation is possible and the exact root cause of what prevent the full expansion of the filter cannot be found.This type of incident is a know complication of the vena cava filter implantations.The complaint rate for this type of incident on venatech lp is low.No corrective action is envisaged.B braun medical sas has provided all the information currently available.In spite of all reasonable efforts being made to obtain further information, at this time we have not met with success.
Event or Problem Description
Filter legs did not expand fully despite manipulation with catheter.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).Investigation results: we did not receive the complaint sample for investigation.Conclusion: without the complaint sample and the batch number for investigation, no thorough investigation is possible and we cannot conclude on the real cause of the incident encountered by the customer.If new elements become available in the future, we will reopen this complaint.This is a rare incident (b)(4), no corrective action is envisaged for the moment.

• Brand Name: SURECAN SAFETY II
• Common Device Name: NON-CORING (HUBER) NEEDLE
• Manufacturer (Section D): B. BRAUN MEDICAL FRANC; 26 rue armengaud; saint cloud,
• Manufacturer (Section G): B.BRAUN MEDICAL SAS FRANCE; 30 avenue des temps modernes; chasseneuil du poitou 86360 ; FR 86360
• Manufacturer Contact: catherine boismenu ; 30 avenue des temps modernes; chasseneuil du poitou, 86360 ; FR 86360
• MDR Report Key: 13190078
• Report Number: 9612452-2022-00002
• Device Sequence Number: 20329625
• Product Code: PTI
• UDI-Device Identifier: 04038653918164
• UDI-Public: 04038653918164
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K010485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023
• 2 Devices were Involved in the Event: 1 2

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: 06/04/2023
• Device Model Number: 5010024
• Device Catalogue Number: 5010024
• Device Lot Number: 36933135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2022
• Supplement Date Received by Manufacturer: 12/10/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• 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
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic