MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. 0.9% SODIUM CHLORIDE IRRIGATION, USP, 1000 ML; CONTAINER, I.V.

Catalog Number R5200-01

Device Problem Contamination (1120)

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

Event Date 02/10/2023

Event Type  malfunction  

Event Description

Debris found when fluid poured into basin on sterile field.

• Brand Name: 0.9% SODIUM CHLORIDE IRRIGATION, USP, 1000 ML
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 16875983
• MDR Text Key: 314645702
• Report Number: 16875983
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2023,02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: R5200-01
• Device Lot Number: J2S947
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2023
• Date Report to Manufacturer: 05/05/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1