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

Model Number 4447005

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/20/2023

Event Type  malfunction  

Event Description

"huber needle safety was stuck and did not work.Accident exposure to blood by wanting to force security.Which finally happened.".

Manufacturer Narrative

The complaint concerns 1 unit of surecan safety ii needle reference 4447005 from batch 23c25g8670.Device history record: the batch record, number 23c25g8670 was reviewed: the batch is within the specifications and no discrepancy was observed.No other similar complaint was reported on the (b)(4) units released in april 2023.Summary of investigations: no device was returned preventing a thorough survey.No pictures/videos of the complaint sample/observed defect were transmitted.Complaints database review: the complaint data base was verified: no increasing trend for this type of incident has been highlighted.Root cause: without the involved sample, conclusive pictures/videos of the defect, no root cause can be identified.Recommendation: to avoid this type of incident, the ifu specifies the procedure to follow.Conclusion: this complaint is not confirmed as no thorough investigation can be performed without the concerned sample/conclusive picture-video/pertinent data.If new element become available in the future, this complaint will be reopened.This type of incident is very rare (< 0.0001%).No actions plan is foreseen at that time.

Event Description

"huber needle safety was stuck and did not work.Accident exposure to blood by wanting to force security.Which finally happened.".

Manufacturer Narrative

The device received is not a bbraun device.

• Brand Name: SURECAN SAFETY II
• Type of Device: NEEDLE 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: 17981072
• MDR Text Key: 326381760
• Report Number: 9612452-2023-00018
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

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
• Device Operator: Health Professional
• Device Model Number: 4447005
• Device Lot Number: 23C25G8670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other