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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number CA32K0/000/000JP
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that during the use of the product, an occlusion in the breathing circuit was found, which did not allow the customer to perform a ventilation properly. No patient injury was reported.
 
Manufacturer Narrative
Based on the leak test results the nonconformance reported as improperly ventilation is not confirmed, however base on the visual inspection the nonconformance as inner blue crushed is confirmed. Based on the investigation results the issue reported is confirmed as supplier issue. Third investigation was opened to our supplier quality (b)(4). Dhr: suspected lots 4105933 / 4138384 were manufactured with (b)(4) units, lots met the requirements to release with no deviations identified during their manufactured.
 
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Brand NamePORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU
Type of DeviceCIRCUIT, 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)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK CT21 6JL
Manufacturer Contact
jim vegel
6000 nathan lane north
7-15-26 fukushima,
minneapolis, MN 55442
MDR Report Key13502223
MDR Text Key288492417
Report Number3012307300-2022-03091
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCA32K0/000/000JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2021
Was the Report Sent to FDA? No
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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