MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX ANESTHESIA BREATHING, EXPANDABLE DABC PEDIATRIC ELBOW; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C49101320J

Device Problem Gas/Air Leak (2946)

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

H3 - other: device has not been returned 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 during self-testing, there was leakage from the circuit.(b)(6) dr., an anesthesiologist, made an inquiry to mr.(b)(6) , the agent in charge.A leak alarm went off when the circuit was connected to the anesthesia machine.It was suspected that the malfunction was with the equipment, so we had the circuit connected to another anesthesia machine; but a leak alarm went off again.It was then suspected there may be a leak from the circuit.There was no patient involvement reported.

Manufacturer Narrative

Investigation summary: one used sample without its original packaging was received for investigation.The returned sample was visually inspected without magnification at 12¿ to 16¿ and normal conditions of illumination according to the inspection procedure.Per visual inspection, it was not possible to detect any issue which could cause the leaking failure mode.The leak test was performed using the leak tester with id: lt-4-2-056, manometer with id 8.0627 with calibration and flowmeter with id 3.0166; the result of the corrugated tubing assembly test was not acceptable because there was an air leak.Results: leaking issue was detected in the leak test; complaint was confirmed.Based on the analysis conducted in the sample provided, it was not possible to detect during the visual inspection any issue could be cause leaking, the possible root cause may be damaged tube, which could have been caused during inappropriate handling of the device outside the icu medical tijuana facilities.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX ANESTHESIA BREATHING, EXPANDABLE DABC PEDIATRIC ELBOW
• 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: 18626629
• MDR Text Key: 334628209
• Report Number: 9617604-2024-00091
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C49101320J
• Device Lot Number: 4392439
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/31/2024
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• 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