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

Catalog Number CA17K0/000/004JP

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

Expiration date and manufacture date are unknown, no information is available based on the reported lot number.510k is blank, device is exempt.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 Description

It was reported that the connection was bent while checking.There was no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

Evaluation codes: updated.Device evaluation: six photos were included for evaluation; damaged connector was observed.One device component was returned for investigation.Visual observation of on the gas sampling line (item number 225-3422-800, lot number 4419607) revealed that one of its connectors was damaged (deformed).No other anomaly was observed.The complaint was confirmed.Root cause cannot be determined since the reported failure mode is not attributable to the manufacturing process.A review of the device history record (dhr) for the received component (lot 4419607) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No action taken.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18861335
• MDR Text Key: 337209069
• Report Number: 2183161-2024-00186
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA17K0/000/004JP
• Device Lot Number: 240111
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/15/2024
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1