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

Model Number	IPN042498
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor found red plug broken before use".No patient involvement reported.
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports "the airway tube of the device was yellowish upon receipt and the red plug cap of the device was observed broken when inspected.The reported failure was verified.In order to simulate the process of shutting and opening of the red plug cap, a retained sample was used.It was observed that the red plug cap will not be stressed when it was handled properly.Dhr was reviewed.No abnormality was found." based on the investigation, the reported complaint was confirmed.The root cause was identified as user related.
Event or Problem Description
It was reported that "the doctor found red plug broken before use".No patient involvemnt reported.

• Brand Name: LMA PROSEAL SIZE 4
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11740483
• Report Number: 9681900-2021-00010
• Device Sequence Number: 3673069
• 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): 04/09/2021

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: 8VMAK9SJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1