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

Model Number 415080

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

We were pulling stock for our clean room and a fluid dispensing pin ref 415080 product code fdc1000 had debris under the sealed package lot 0061894571 exp 6/30/2028.

• Brand Name: FLUID DISPENSING CONNECTOR
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; bethlehem PA 18018 3524
• MDR Report Key: 18588923
• MDR Text Key: 333982263
• Report Number: MW5150768
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 415080
• Device Lot Number: 0061894571
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose