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

Catalog Number 4251644-01

Device Problem Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen (b)(4) internal report # (b)(4).Within the current restriction for covid-19 the sample cannot be sent for investigation.Without the actual sample (or device), a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.Device history record review (dhr): reviewed the device history record and no abnormalities found during in process and final control inspection.If additional pertinent information becomes available, a follow up report will be submitted.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): faulty product - biological risk.After having placed a venous access in the patient, after having extracted the mandrin from the cannula, the operator punctured himself with the tip of the mandrin which was not covered with the automatic cover system of the tip that even if it was automatically snapped, it did not covered the needle tip.Consequence: operator puncture, with risk of biological contamination.

• Brand Name: INTROCAN SAFETY®
• Type of Device: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen,
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen,
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4842408332
• MDR Report Key: 9805904
• MDR Text Key: 196307370
• Report Number: 9610825-2020-00050
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: 4251644-01
• Device Lot Number: 18N03G8301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2018
• 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