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

Model Number	450952-NL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, the breathing filter got easily detached from the breathing circuit.No patient involvement.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated h10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Sample received: one (1) sample was returned for evaluation from p/n 450952-nl, the returned sample was received inside a plastic bag without its original packaging.Visual inspection: the sample was visually inspected: results: breathing filter is loose from adult tube bushing.Dimensional test: samples were measured on equipment push-pull scale id# (b)(6) (calibration due date 08/2022) per procedure md01-106 rev.002 test for iso insertion depth / table section # 1: tube bushing test: specification: ref.Id diameter 0.883 functional testing per iso 5356-1.Iso tapered fitting insertion force: size 15mm need to be inspected with a minimum and maximum force (7.1 lbs ? 8.7 lbs) current sample result: taper verification of the pieces are accepted with a minimum force of 7.1 lbs.And maximum force of 8.7 lbs.Variation in the molding process could generate some pieces with the od out of specification.The cause of the reported problem was traced to the manufacturing process.Lots 4112669 was manufactured with (b)(4) units; lots met the requirements to release with no deviations identified during their manufactured.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• 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): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 14102947
• Report Number: 3012307300-2022-06303
• Device Sequence Number: 4805755
• Product Code: CAI
• UDI-Device Identifier: 15019315075834
• UDI-Public: 15019315075834
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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 Model Number: 450952-NL
• Device Catalogue Number: 450952-NL
• Device Lot Number: 4112669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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