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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number C45101796D-NL
Device Problems Break (1069); Moisture Damage (1405); Obstruction of Flow (2423); Moisture or Humidity Problem (2986); Output Problem (3005)
Patient Problem Respiratory Insufficiency (4462)
Event Type  malfunction  
Manufacturer Narrative
B3: date of event; d4: lot number, expiration date, udi number and h4: device manufacture date is unknown, no information has been provided to date.G5: 510k is blank device is exempt.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 customer had issues with the anesthesia circuits that are currently in their circulation.Some have had cracks in the corrugated tubing itself, and some had issues with the dime sized filter in the circuit.The filter gets soaked with moisture and the thick sponge within the filter gets water logged and prevents medical staff from ventilating the patient.An esophagectomy patient at the most critical part of the case when making the anastomosis in the chest could not be ventilated due to the filter issue.
 
Manufacturer Narrative
No product was returned.We are unable to confirm the reported complaint.If the product is returned, icu medical will reopen this complaint for further investigation.A review of the device of the device history records could not be completed as no lot number was provided by the customer.
 
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Brand Name
PORTEX ANESTHESIA BREATHING CIRCUIT
Type of Device
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key16722297
MDR Text Key313115597
Report Number3012307300-2023-03971
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberC45101796D-NL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/22/2023
Initial Date FDA Received04/12/2023
Supplement Dates Manufacturer Received09/07/2023
Supplement Dates FDA Received09/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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