MAUDE Adverse Event Report: AIR TECHNIQUES INC. MONARCH; DISINFECTANT MEDICAL DEVICE

Model Number H6340

Device Problems Product Quality Problem (1506); Device Contamination With Biological Material (2908); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 02/21/2018

Event Type  malfunction  

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.).

Event Description

Office opened 2 bottles of line cleaner and noticed that there was mold in the bottles.

Event Description

Office opened 2 bottles of line cleaner and noticed that there was mold in the bottles.

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).

• Brand Name: MONARCH
• Type of Device: DISINFECTANT MEDICAL DEVICE
• Manufacturer (Section D): AIR TECHNIQUES INC.; 1295 walt whitman road; melville NY 11747
• MDR Report Key: 7554707
• MDR Text Key: 109773336
• Report Number: 2428225-2018-00002
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/22/2018,08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: H6340
• Device Catalogue Number: H6340
• Device Lot Number: G289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Was the Report Sent to FDA?: No
• Event Location: Other
• Date Report to Manufacturer: 02/22/2018
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 02/21/2018
• Supplement Dates FDA Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1