MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH ADJ FLANGE NON LATEX NASA; AIRWAY, NASOPHARYNGEAL

Model Number	IPN042921
Medical Device Problem Code	Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "customer is finding condensation inside the packaging".No patient involvement reported.
Event or Problem Description
It was reported "customer is finding condensation inside the packaging".No patient involvement reported.
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer returned a representative sample from another lot number.A visual exam was performed and it was observed that the sample contained vapors inside the packaging.A device history record review was performed and no relevant findings were identified.Based on the visual exam, the complaint has been confirmed.A capa was opened to further address this issue.
Event or Problem Description
It was reported "customer is finding condensation inside the packaging".No patient involvement reported.
Additional Manufacturer Narrative
(b)(6) the actual device was not returned; however, the customer returned a representative sample from another lot number.A visual exam was performed and it was observed that the sample contained vapors inside the packaging.A device history record review was performed and no relevant findings were identified.Based on the visual exam, the complaint has been confirmed.A capa was opened to further address this issue.Corrected data: section h.6.-type of investigation code corrected to 4103.

• Brand Name: RUSCH ADJ FLANGE NON LATEX NASA
• Common Device Name: AIRWAY, NASOPHARYNGEAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12579964
• Report Number: 8040412-2021-00244
• Device Sequence Number: 1101163
• Product Code: BTQ
• UDI-Device Identifier: 14026704336156
• UDI-Public: 14026704336156
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2021

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
• Device Expiration Date: 08/28/2025
• Device Model Number: IPN042921
• Device Catalogue Number: 18542028
• Device Lot Number: KMA20J1042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 03/09/2022; 03/09/2022
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 03/09/2022; 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown