MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY® 2; CATHETER, INTRAVASCULAR, THE

Catalog Number 4242006-02

Device Problem Fail-Safe Problem (2936)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: brief inquiry description nurse stated that the safety came off and she had a needle stick.Detailed inquiry description one nurse successfully started and iv, set the stylet down on the table and proceeded to place trash on top of the stylet.A second nurse came to clean up the trash, did not know the stylet was under the trash.As she was picking up trash she stated the safety moved or fell off leaving the needle exposed and she was stuck by the needle.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).A device history record (dhr) review was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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.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: INTROCAN SAFETY® 2
• Type of Device: CATHETER, INTRAVASCULAR, THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18971689
• MDR Text Key: 338682206
• Report Number: 9610825-2024-00221
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046955745944
• UDI-Public: (01)04046955745944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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 Catalogue Number: 4242006-02
• Device Lot Number: 23M15G8273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2023
• 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