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

Model Number	C45091795D-NL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the breathing bag broken at the bushing.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No sample was returned for evaluation; however, operations and records were reviewed in order to ensure that all complied with gmps (good manufacturing practices) and procedures.The breathing bag tape assembly, training records and visual inspection found no discrepancies.Quality also takes a sample and level inspection per lot, in order to verify anesthesia breathing circuits are not missing any components.The most probable root cause is production personnel did not detect the incorrect assembly of the tape.D5 and g5 are unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• 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: 15415137
• Report Number: 3012307300-2022-19043
• Device Sequence Number: 2544809
• Product Code: CAI
• UDI-Device Identifier: 15019517068696
• UDI-Public: 15019517068696
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/13/2022

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
• Device Expiration Date: 11/04/2021
• Device Model Number: C45091795D-NL
• Device Catalogue Number: C45091795D-NL
• Device Lot Number: 3723637
• 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: 07/08/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown