MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. ANESTHSIA BREATHING KIT - EXPANDABLE CIRCUITS, ADULT; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Model Number 670003

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that the device leaked during a pre-use check, and a tiny hole was found in the anesthesia bag.There was patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

B3.Date of event: month and year of event have been provided, but day is unknown.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: d.2.Common device name: filter, bacterial, breathing-circuit d.2.Medical device type: cah d4.Lot number, expiration date, udi, and h4.Manufacture date are unknown, as the reported lot# 231124 was not found for the reported catalog# ca13b0/4k2/000jp.D5.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.

Manufacturer Narrative

Device evaluation: one used unit without it's original packaging was returned for investigation.The breathing bag (item number updated) was returned and lot number determined.Visual inspection fond a tear was found in it.No other anomaly was observed.It was considered that the tear was made before the component had been supplied to the manufacturing site.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.This issue will continue to be monitored and further actions taken accordingly to address the root cause.

• Brand Name: ANESTHSIA BREATHING KIT - EXPANDABLE CIRCUITS, ADULT
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18752043
• MDR Text Key: 336785465
• Report Number: 2183161-2024-00157
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 670003
• Device Catalogue Number: 670003---802
• Device Lot Number: 4407705
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/01/2024
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• 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