MAUDE Adverse Event Report: HIMEDIA LABORATORIES PRIVATE LIMITED HICOMBI DUAL PERFORMANCE TRANS; CULTURE MEDIA, GENERAL NUTRIENT BROTH

Lot Number LQF0006

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

Determination of carbapenem resistant acinetobacter junii producing rare carbapenemase enzyme found in a transport media bottle for cs fluids.

• Brand Name: HICOMBI DUAL PERFORMANCE TRANS
• Type of Device: CULTURE MEDIA, GENERAL NUTRIENT BROTH
• Manufacturer (Section D): HIMEDIA LABORATORIES PRIVATE LIMITED
• MDR Report Key: 17925721
• MDR Text Key: 325798588
• Report Number: MW5146880
• Device Sequence Number: 1
• Product Code: JSC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: LQF0006
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male