MAUDE Adverse Event Report: RICCA CHEMICAL COMPANY LLC SODIUM CHLORIDE, 0.9% (W/V) ISOTONIC SALINE; SOLUTION, ISOTONIC

Lot Number 230G17

Patient Problem Insufficient Information (4580)

Event Date 03/05/2024

Event Type  Injury  

Event Description

Non-sterile saline- sodium chloride, 0.9% (w/v), isotonic solution - manufacturer ricca, lot # 2307g17 expiration date 6/2025 - was used on tissue specimens in the microbiology lab, which resulted with burkholderia cepacia.This finding is suspected to be a contaminate.The in use saline and non-opened saline was cultured, resulting in burkholderia cepecia x2.Scant growth of burkholderia cepacia.Reference report #mw5153964.

• Brand Name: SODIUM CHLORIDE, 0.9% (W/V) ISOTONIC SALINE
• Type of Device: SOLUTION, ISOTONIC
• Manufacturer (Section D): RICCA CHEMICAL COMPANY LLC
• MDR Report Key: 19141982
• MDR Text Key: 340647738
• Report Number: MW5153963
• Device Sequence Number: 1
• Product Code: JCE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 230G17
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White