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

Model Number	C1034J
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before opening the package, the customer found a stain on the connector.No patient involvement.
Additional Manufacturer Narrative
Device evaluation: the device was returned for investigation.Three (3) pictures were attach, during the analysis conducted it could be observed a top view of a circuit breathing inside of sealing packaging, one of them is made a focus an the connector where a stain is observed.Visual inspection results: the bag of the circuit breathing is sealed and a stain on a connector was detected inside of it; thus, the failure mode reports is confirmed.The occurrence of this failure condition could be caused by: unclean work station.The cause of the reported problem was traced to the manufacturing process.A dhr (device history review) was performed and no problems or issues were identified during this dhr review., corrected data: gmdn: 37704; d3: mfg.Name: hythe; d4: udi#: (b)(4) ; g5: (510k) nr: k002506; h4: dev mfg.Date: 17-nov-2021; d4: dev.Exp.Date: 06-nov-2024.

• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 14427582
• Report Number: 3012307300-2022-08946
• Device Sequence Number: 17774722
• Product Code: CAI
• UDI-Device Identifier: 00351688433469
• UDI-Public: 00351688433469
• 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): 12/15/2022

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: 11/06/2024
• Device Model Number: C1034J
• Device Catalogue Number: C1034J
• Device Lot Number: 4218309
• 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: 04/18/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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