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

Model Number IPN042498

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event 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.

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 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
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11773465
• MDR Text Key: 257240641
• Report Number: 9681900-2021-00014
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 04026704319688
• UDI-Public: 04026704319688
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1