MAUDE Adverse Event Report: SMITH¿S MEDICAL INTERNATIONAL LTD. PORTEX COLOR CODED GUEDEL AIRWAY; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Catalog Number	100/322/100
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the colored plastic insert fell out when airway was in patients' mouth.The airway was removed and replaced with a new airway.The staff disposed of defective device, so it is not available for evaluation.The item was removed from patients' mouth and replaced with a different airway.There was patient involvement, but no patient harm reported.
Additional Manufacturer Narrative
Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A scar (supplier corrective action request) was issued and requested the manufacturer (well lead) to conduct a detailed investigation with the photos.

• Brand Name: PORTEX COLOR CODED GUEDEL AIRWAY
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): SMITH¿S MEDICAL INTERNATIONAL LTD.; bijsterhuizen 22 ¿ 08; wijchen 6604 LD; NL 6604 LD
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19566398
• Report Number: 3012542015-2024-00031
• Device Sequence Number: 3981059
• Product Code: CAE
• UDI-Device Identifier: 15019315071430
• UDI-Public: (01)15019315071430(17)270901(10)2210021808
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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 Catalogue Number: 100/322/100
• Device Lot Number: 2210021808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown