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

Model Number 4252519-02

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the device involved in the reported event are being made.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by user facility: noticed some fur on the tip upon opening the package.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Five (5) samples were provided for evaluation.Based on the sample analysis, there is no contaminant found on the bevel tip as described by the customer.The reported defect was unable to be confirmed.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non- conformances were noted during the in process or final product inspection.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
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12050548
• MDR Text Key: 271563375
• Report Number: 9610825-2021-00239
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4252519-02
• Device Catalogue Number: 4252519-02
• Device Lot Number: 20N12G8303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2021
• 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