MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY® 3; CATHETER,INTRAVASCULAR,THE

Model Number 4251128-02

Device Problem Fail-Safe Problem (2936)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2022

Event Type  malfunction  

Event Description

As reported by the user facility: "the iv was started and had a flash into the base of the iv set.I went to pull the needle out of the catheter and it would not pull out.I was pulling straight back.I put pressure onto the catheter wings and pulled the needle straight back and it still would not release.I pushed down on the catheter more and used more force to pull the needle back and it finally released after a couple of tries.When the needle came out of the catheter, the needle guard was not on the end of the needle.It was three quarters of the way down the needle, toward the base.I believe this device was defective.".

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).A photo was provided for further evaluation.Based on the evaluation results, it was observed that the location of the location of the safety clip is in the middle of the cannula and not covering the cannula.However, without the actual sample to evaluate the exact root cause was unable to be determined.The manufacturer evaluated their production processes and were unable to identify a process that would create this defect.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: INTROCAN SAFETY® 3
• 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: 16093797
• MDR Text Key: 308618629
• Report Number: 9610825-2022-00552
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046964014017
• UDI-Public: (01)04046964014017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2023

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: 4251128-02
• Device Catalogue Number: 4251128-02
• Device Lot Number: 21L02G8371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2021
• 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