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

Model Number	IPN042498
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the rear cuff of serial # (b)(4) has wrinkle and has difficulty of deflation from its red plug".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports a visual exam was performed and it was observed that the airway tube of the device was yellowish due to multiple uses.Functional testing was also performed and the cuff was able to be inflated and deflated normally with the check valve; however, it was found that the cuff could not be deflated when red plug was opened.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.The manufacturing site reports "the opening of the red plug was blocked by the valve hence the cuff could not be deflated even when the red plug was opened.The device has been reported undergone multiple re-uses with less than 40 times.The most probable root cause could have been due to excessive force applied to the valve inside the blue inflation balloon when inflating or deflating the device over these re-uses, the valve had sink further into the tubing which resulted the red plug opening being blocked by the valve.Nonetheless, this device is still functional and can be still deflated and inflated using the check valve.".
Event or Problem Description
It was reported that "the rear cuff of serial # (b)(4) has wrinkle and has difficulty of deflation from its red plug".No patient involvement reported.

• Brand Name: LMA PROSEAL SIZE 4
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11773465
• Report Number: 9681900-2021-00014
• Device Sequence Number: 3438660
• 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): 04/20/2021

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: 8VVAJLJ9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1