MAUDE Adverse Event Report: B.BRAUN MEDICAL SAS SURECAN SAFETY II; NEEDLES FOR ACCESS PORT

Model Number	4447051-02
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
I accessed the above patient's port with the new 20g port needles.When i drew back, blood immediately began seeping around the needle and running down the patient's chest.It required me to remove the needle and apply light pressure for 30 seconds and re-access port.
Additional Manufacturer Narrative
Batch history review: we have checked the manufacturing file of batch nr21b10g8671 which complies with our specifications and does not present any discrepancy.Another similar complaint was reported to us on this batch of needles released in february 2021.Investigation results: we did not receive the complaint sample for investigation.Conclusion: without the complaint sample for investigation, no thorough investigation is possible and we cannot conclude on the real cause of the incident.If new element become available in the future, we will reopen this complaint.This is a rare incident (<0.0001%), no corrective action is envisaged for the moment.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.The actual defective device is a valuable tool in investigating the cause of this incident.Review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: SURECAN SAFETY II
• Common Device Name: NEEDLES FOR ACCESS PORT
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• 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: 13383751
• Report Number: 9612452-2022-00004
• Device Sequence Number: 16994397
• Product Code: PTI
• UDI-Device Identifier: 04046955156399
• UDI-Public: 04046955156399
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 01/10/2024
• Device Model Number: 4447051-02
• Device Catalogue Number: 4447051-02
• Device Lot Number: 21B10G8671
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male