MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. ANESTHESIA BREATHING CIRCUITS; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Catalog Number C49291349-NLJ

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

Date of event: month and year of event have been provided, but day is unknown.Other operator of device: operator of device is unknown.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 device had loose connections and leaked air.There was no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

Investigation summary: three photos were included for evaluation; flash was observed in the connector.The sample was received without the original package.During visual inspection, flash was observed in connector, confirming the complaint.However, a root cause was not determined.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: ANESTHESIA BREATHING CIRCUITS
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18779705
• MDR Text Key: 337129384
• Report Number: 9617604-2024-00177
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: C49291349-NLJ
• Device Lot Number: 4392464
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2024
• Date Manufacturer Received: 03/06/2024
• 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