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

Model Number 4252519-02

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 10/14/2022

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: detailed inquiry description: the nurse noticed that there is a debris or a plastic like speck on the side of a brand new iv catheter when he opened the package and took the cap off the needle.No injury reported.

Manufacturer Narrative

Event 1: this report has been identified as b.Braun medical internal report number (b)(4).One (1) unused sample in opened packaging and photo were provided for evaluation.Visual inspection of the photograph notes a white fiber like contaminant found on the capillary surface.The actual origin of contaminant was unable to be identified from this picture.Through visual inspection of the sample, it was observed that no similar white contaminant was on the returned sample and/or the packaging.Further analysis on the origin of the particle contaminate is not possible.A review of manufacturing records was performed and indicated that there were no quality issues during the manufacturing of this lot related to the reported issue.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: 15652898
• MDR Text Key: 304825803
• Report Number: 9610825-2022-00426
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046963165949
• UDI-Public: (01)04046963165949
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4252519-02
• Device Catalogue Number: 4252519-02
• Device Lot Number: 22E15G8361
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2022
• 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