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	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "when the proseal was being introduced into a patient, the tubing snapped off at the connector site.Part of tubing remained inside connector".No patient harm or injury reported.Patient condition reported as fine.
Event or Problem Description
It was reported "when the proseal was being introduced into a patient, the tubing snapped off at the connector site.Part of tubing remained inside connector".No patient harm or injury reported.Patient condition reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "the device was discol oured as compared with a blank new retained sample.On closer observation at the failure location, there were some jagged edges (symptoms of cracks due to force) on the broken connector.The jagged edges at where the connector split appeared to be ruptured by force." a device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint has been confirmed.The root cause is user related.A concentrated detergent or overrun holding time could have possibly adversely impact the sturdiness of the connector properties which could result in connector broken when external forces applied to it.

• Brand Name: LMA PROSEAL SIZE 4
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11881002
• Report Number: 9681900-2021-00015
• Device Sequence Number: 13780589
• Product Code: CAE
• UDI-Device Identifier: 04026704319688
• UDI-Public: 04026704319688
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 05/06/2021

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: 8VUAJ9VX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1