MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX ANESTHSIA BREATHING CORRUGATED CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C37101330-NLJ

Device Problem Gas/Air Leak (2946)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

D4: lot number, udi number, expiration date, and h4: manufacture date are 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 Description

It was reported that "there was a leak reaction during pre-use inspection." there was no patient involvement and no harm/adverse event reported.

Manufacturer Narrative

H3 and h6 - evaluation codes: updated.Device evaluation: four photos were included for evaluation; a hole was observed in the circuit.One (1) sample was received without the original package.Visual inspection found it was not possible to detect any issue which could cause the leaking failure mode.The result of the corrugated tubing assembly test was not acceptable because there was 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 has been provided, therefore no device history report (dhr) review could be performed.

• Brand Name: PORTEX ANESTHSIA BREATHING CORRUGATED CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18981096
• MDR Text Key: 338767310
• Report Number: 9617604-2024-00256
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: C37101330-NLJ
• 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