MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number	CP12B0/000/000JP
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during pre-use inspection, there was a leak from the circuit.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
G2 - report source, corrected.H4 - device mfg date is unknown, no information is available based on reported lot number.H3 and h6.Evaluation codes: updated.One device sample was received in used condition in a plastic bag.Four photos were also received and evaluated.Per visual inspection, it was not possible to detect any issue which could cause the leaking failure mode.A leak test was performed, and the device failed confirming the complaint.Corrective actions are in process to address root cause investigation.A device history record (dhr) review was not performed.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20239647
• Report Number: 3012307300-2024-09367
• Device Sequence Number: 8090250
• Product Code: CAI
• UDI-Device Identifier: 15019517103434
• UDI-Public: (01)15019517103434(17)250928(10)230727
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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 Expiration Date: 09/28/2025
• Device Catalogue Number: CP12B0/000/000JP
• Device Lot Number: 230727
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 11/12/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown