MAUDE Adverse Event Report: RUSCH ADJ FLANGE NON LATEX NASA; AIRWAY, NASOPHARYNGEAL

Model Number	IPN042923
Medical Device Problem Code	Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "i spoke with a staff member who described one of the 18542032 units as having condensation within the packaging".No patient involvement reported.
Event or Problem Description
It was reported "i spoke with a staff member who described one of the 18542032 units as having condensation within the packaging".No patient involvement reported.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The manufacturing site reports that "the fitr test result on vapor analysis on the same complaint nature, the vapor is identified as calcium nitrate.It is part of material used during production process of making this product.From the analysis, due to porosity of synthetic material, based material for this product the reported defect could be occurred and without chlorination lead to holding calcium nitrate in layers, it will be vaporized at lower temperature (<20 celsius) and high relative humidity 90%." the manufacturer also reports that "the chemical is common part of these products and their biocompatibility was tested and confirmed.However, in the absence of actual sample being returned and limited information available for this complaint, further investigation could not be conducted." a capa was opened to further address this issue related to vapor inside the packaging.

• Brand Name: RUSCH ADJ FLANGE NON LATEX NASA
• Common Device Name: AIRWAY, NASOPHARYNGEAL
• MDR Report Key: 11858651
• Report Number: 8040412-2021-00146
• Device Sequence Number: 3237375
• Product Code: BTQ
• UDI-Device Identifier: 14026704336170
• UDI-Public: 14026704336170
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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
• Operator of Device: No Information
• Device Model Number: IPN042923
• Device Catalogue Number: 18542032
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1