MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ANESTHESIA SINGLE LIMB CIRCUIT; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Catalog Number CA32K0/4A2/000JP

Device Problem Gas/Air Leak (2946)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

Udi number, expiration date, 510k number and manufacture date are not available based on the reported lot number.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 a leak was discovered upon pre-testing/during priming.No patient involvement and no harm/adverse event reported.

Manufacturer Narrative

Evaluation codes: updated.Device evaluation: four photos were included for evaluation; damage was observed in the circuit.One sample was returned for investigation without the original package.The returned component was identified to be item number c1034j.The lot number was not able to be determined.Per visual inspection of the returned component damage was observed in the circuit.Functional testing found the corrugated tubing assembly test was not acceptable because there was an air leak.Leaking issue was detected in the leak test; complaint was confirmed.This issue will continue to be monitored and further actions taken accordingly to determine root cause.No lot number was determined for the returned component, therefore no device history report (dhr) review could be performed.

• Brand Name: PORTEX ANESTHESIA SINGLE LIMB CIRCUIT
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18980994
• MDR Text Key: 338671350
• Report Number: 3012307300-2024-01675
• Device Sequence Number: 1
• Product Code: OFP
• 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: 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: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CA32K0/4A2/000JP
• Device Lot Number: 231220
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/07/2024
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1