MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	VP1343
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there should have been two breathing filters in the circuit; but instead, there has been only one received.No patient injury was reported.
Additional Manufacturer Narrative
No additional information was received.The sample was received in unused conditions within its original packaging.It was visually inspected at a distance of 12 in under normal lighting to received unit, in order to detect any missing components.The sample only had one (1) filter instead of two (2).The reported problem was confirmed and deemed due to manufacturing.Qalert was generated on 28-aug-2020 to notify production personnel of missing filter defect.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: PORTEX
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15487079
• Report Number: 3012307300-2022-20308
• Device Sequence Number: 14812248
• Product Code: CAI
• UDI-Device Identifier: 15019517162318
• UDI-Public: 15019517162318
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2022

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 Expiration Date: 04/01/2023
• Device Model Number: VP1343
• Device Catalogue Number: VP1343
• Device Lot Number: 3969490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2022
• Initial Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown