MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. FLUID DISPENSING CONNECTOR; DISPENSER, LIQUID MEDICATI

Model Number 415080

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 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: it was reported that particulate matter was observed in the imp-iv bags after the infusion was prepared.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Further investigation of the complaint is not possible.  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: FLUID DISPENSING CONNECTOR
• Type of Device: DISPENSER, LIQUID MEDICATI
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 11970446
• MDR Text Key: 258649937
• Report Number: 2523676-2021-00165
• Device Sequence Number: 1
• Product Code: KYX
• UDI-Device Identifier: 04022495820105
• UDI-Public: 04022495820105
• Combination Product (y/n): N
• PMA/PMN Number: K800437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 415080
• Device Catalogue Number: 415080
• Device Lot Number: 0061732516
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1