MONARCH
Received May 30, 2018 · Event occurred Feb 21, 2018
Report 2428225-2018-00002 · MDR key 7554707
Device
Generic name
Disinfectant Medical Device
Manufacturer
Air Techniques Inc.Model number
H6340Catalog number
H6340
Lot number
G289
Product problems
- Product Quality Problem
- Device Contamination With Biological Material
- Appropriate Device Problem Term/Code Not Available
- Product Quality Problem
- Device Contamination With Biological Material
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
ON 3/20/2018 PRODUCT IS CURRENTLY BEING EVALUATED BY SUPPLIER. SCAR # (B)(4) WAS ISSUED TO SUPPLIER ON 3/2/2018. ON 5/25/2018 REPORT WAS PREVIOUSLY SUBMITTED ON TIME WITH SUCCESSFUL ACK3S RESPONSES BUT ON 5/23/2018 WE NOTICED THAT THE MFR REPORT # ON THE ORIGINAL REPORT WAS INCORRECT. WE HAVE CORRECTED THE MFR REPORT # (2428225-2018-00002.).
Description of Event or Problem
OFFICE OPENED 2 BOTTLES OF LINE CLEANER AND NOTICED THAT THERE WAS MOLD IN THE BOTTLES.
Description of Event or Problem
OFFICE OPENED 2 BOTTLES OF LINE CLEANER AND NOTICED THAT THERE WAS MOLD IN THE BOTTLES.
Additional Manufacturer Narrative
8/1/2018 (B)(4) (SUPPLIER) SENT THE BOTTLES TO AN EXTERNAL LAB 'ACCELERATED ANALYTICAL LABORATORIES (AAL)' TO IDENTIFY THE CONTAMINATION. AAL PROTOCOL REVEALED THAT AT THE TIME OF RECEIPT THE FOREIGN MATERIAL WAS NON-VIABLE. AAL REPORTS THAT THE FOREIGN MATERIAL APPEARS FROM THE MICROSCOPIC REVIEW TO BE VISUALLY SIMILAR TO MOLD HOWEVER THIS WAS NOT CONFIRMED MICROBIOLOGICALLY. PER THE REPORT, THE ACTIVE INGREDIENTS OF THE BOTTLE INHIBIT THE GROWTH OF THE MOLD. THEREFORE, IT IS BELIEVED THAT THE MATERIAL (POSSIBLY MOLD) WAS MOST LIKELY INTRODUCED IN THE BOTTLES FROM AN EXTERNAL SOURCE. (B)(4).
Remedial action
- Inspection