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

Catalog Number 4251628-02

Device Problem Fail-Safe Problem (2936)

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

Event Date 11/10/2023

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 per medwatch form mw5148304: "hile inserting an iv (intravenous catheter) into a patient in the or (operating room) and after i advanced the catheter into the vein and tried to remove the needle, the needle met some resistance coming out and the safety tip actually snapped off the needle and remained in the catheter.The needle portion was removed, but the safety tip snapped off the end of the needle and remained in the catheter.We let some blood flow through the catheter, and it pushed the safety tip out and we were able to grab it with a surgical instrument.The safety tip that was removed was intact and there was nothing left behind in the catheter or in the patient." brand name: 22gaugex1 in safety iv catheter.

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®
• 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: 18355017
• MDR Text Key: 330876664
• Report Number: 9610825-2023-00623
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046963166021
• UDI-Public: (01)04046963166021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

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: 4251628-02
• Device Lot Number: 22A28G8362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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