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

Catalog Number CA32B0/400/004JP

Device Problem Gas/Air Leak (2946)

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

Event Date 04/01/2023

Event Type  malfunction  

Event Description

It was reported that an air leak alarm was detected during the pre-use check.It was reported that there no additional information is available for this complaint.

Manufacturer Narrative

B3: month and year of event have been provided, day is unknown.D4: expiration date and h4: manufacture date are unknown, no information is available based on reported lot number.G5: no 510k as 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.

Manufacturer Narrative

One used device (pre-use check) was received.Visual inspection noted a black marking by the customer and a tear was found in the center of the corrugate tube.A leak was detected during functional testing confirming the complaint.A root cause could not be determined however the damage could have occurred during transportation and/or handling of the product.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.This issue will be monitored, and further actions taken accordingly.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Type of Device: 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16835055
• MDR Text Key: 314268580
• Report Number: 3012307300-2023-04744
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: CA32B0/400/004JP
• Device Lot Number: 230213
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1