MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; ATTACHMENT, BREATHING

Model Number 100/905/300

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2020

Event Type  malfunction  

Event 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
• Type of Device: ATTACHMENT, BREATHING
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• MDR Report Key: 9986841
• MDR Text Key: 188538845
• Report Number: 3012307300-2020-03371
• Device Sequence Number: 1
• Product Code: BYE
• UDI-Device Identifier: 15019315061066
• UDI-Public: 15019315061066
• Combination Product (y/n): N
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1