MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number	IPN042498
Medical Device Problem Codes	Inflation Problem (1310); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "a brand new lma proseal #4 was opened to use for inspection/functional testing.The nurse at clinic found the cuff had difficulty of deflating/inflating.It seems something wrong with its red plug".No patient involvement reported.
Event or Problem Description
It was reported "a brand new lma proseal #4 was opened to use for inspection/functional testing.The nurse at clinic found the cuff had difficulty of deflating/inflating.It seems something wrong with its red plug".No patient involvement reported.2 mdrs submitted: 9681900-2021-00022 - difficult to deflate cuff on device; 9681900-2021-00021 - difficult to inflate cuff on device.
Additional Manufacturer Narrative
Qn# (b)(4).The device was returned by the customer and sent to the manufacturing site for investigation.The manufacturing site reports: "the device can be deflated and inflated with the check valve.Air releasing via red plug is sluggish.There was no usage record card to indicate the date of initial use and last use of the device.The date of reprocessing the device, reprocessing details and autoclave parameter is unknown.The root cause of the incident is unidentifiable." corrected data: section f10: medical device problem code corrected to 1310 section h6: medical device problem code corrected to 1310.

• Brand Name: LMA PROSEAL SIZE 4
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 12246326
• Report Number: 9681900-2021-00021
• Device Sequence Number: 19611189
• Product Code: CAE
• UDI-Device Identifier: 04026704319688
• UDI-Public: 04026704319688
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/08/2021

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: IPN042498
• Device Catalogue Number: 150040
• Device Lot Number: 8VUAN7R2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1