MAUDE Adverse Event Report: PORTEX; ATTACHMENT, BREATHING

Model Number	100/905/300
Medical Device Problem Codes	Disconnection (1171); Loose or Intermittent Connection (1371); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the one-way valve to a smiths medical pneupac disposable circuit became disconnected.It was reported that the connector was easily detached from the product following attaching an hme filter.There were no reported adverse effects.

• Brand Name: PORTEX
• Common Device Name: ATTACHMENT, BREATHING
• MDR Report Key: 9986839
• Report Number: 3012307300-2020-03372
• Device Sequence Number: 17253910
• Product Code: BYE
• UDI-Device Identifier: 15019315061066
• UDI-Public: 15019315061066
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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: 100/905/300
• Device Catalogue Number: 100/905/300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/22/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1