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 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Device history record the record file of the involved batch was reviewed: the batch was manufactured within the specifications and no discrepancy was observed.No other similar complaint was reported on the units released in september 2022.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 to activate the safety mechanism.Conclusion this complaint is not confirmed as no thorough investigation can be performed without the concerned sample.If new element become available in the future, this complaint will be reopened.This type of incident is very rare (b)(4).No actions plan is foreseen at that time.

Event Description

Description of malfunction/failure:needle does not spring back naturally after removing needle description of event:this butterfly port needle is safe (i.E., stab resistant) and should rebound directly after removing the needle.However, on (b)(6) 2023, the nurse pulled out the needle normally after flushing, but this consumable did not perform the rebound action and malfunctioned, causing needle stick injury to the nurse and occupational exposure event.Preliminary handling of event:according to the hospital occupational exposure process, carry out physical examination for stabbing nurses, and report the abnormalities to medical device adverse events.

• 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: 18541553
• MDR Text Key: 333442134
• Report Number: 9612452-2024-00004
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4447005
• Device Lot Number: 22K05G8670
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• 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