MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH CRVD REINF CUFF ET 8.0MM

Model Number	IPN040971
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the balloon inflation was not normally operated and the product was not fixed during intubation".No patient injury or harm reported.Patient condition reported as "fine".
Event or Problem Description
It was reported "the balloon inflation was not normally operated and the product was not fixed during intubation".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was then performed and the cuff and pilot balloon were inflated to 25mbar using a calibrated endotest meter.No issues were encountered.The sample was then immersed in water for leak testing.No air bubbles were observed coming from the cuff or pilot balloon indicating no leakage.The complaint of leakage could not be confirmed.There were no issues found with the returned sample.The device functioned as intended.

• Brand Name: RUSCH CRVD REINF CUFF ET 8.0MM
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11447119
• Report Number: 8040412-2021-00070
• Device Sequence Number: 4046973
• Product Code: BTR
• UDI-Device Identifier: 14026704340986
• UDI-Public: 14026704340986
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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: IPN040971
• Device Catalogue Number: 103902-000080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1