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	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the 15mm connector was completely broken.It happened when the nurse at hospital tried connecting hme (heat moisture exchanger) to an elbow connector ((b)(4): fixed elbows 1997000) which was connected to the lma proseal after intubation.The broken 15mm connector was disposed".No patient harm or injury reported.Patient condition reported as "fine".
Event or Problem Description
It was reported that "the 15mm connector was completely broken.It happened when the nurse at hospital tried connecting hme (heat moisture exchanger) to an elbow connector (japan medicalnext/intersurgical: fixed elbows 1997000) which was connected to the lma proseal after intubation.The broken 15mm connector was disposed".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 discolo ured 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.Dhr was reviewed.No abnormality was found." based on the investigation, the reported complaint was confirmed.The root cause was identified as user related.A concentrated detergent or overrun holding time could have possibly adversely impact the sturdiness of the connector properties.Per ifu recommendation, process lma proseal with mild detergent such as enzymatic cleaning agents with autoclaving time (held time) of 10 minutes at 134 c.

• Brand Name: LMA PROSEAL SIZE 4
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11740625
• Report Number: 9681900-2021-00009
• Device Sequence Number: 11680736
• 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: Health Professional
• Device Model Number: IPN042498
• Device Catalogue Number: 150040
• Device Lot Number: 8VTAAS8A
• 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: 05/25/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEAT MOISTURE EXCHANGER; HEAT MOISTURE EXCHANGER