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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. INTUBATION- PORTEX ENDOTRACHEAL TUBE; INTUBATION CONNECTOR ACCESSORY

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SMITHS MEDICAL INTERNATIONAL, LTD. INTUBATION- PORTEX ENDOTRACHEAL TUBE; INTUBATION CONNECTOR ACCESSORY Back to Search Results
Model Number 54-05-112
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
Event Type  malfunction  
Manufacturer Narrative
The device is a supplied item to which smiths medical makes no changes during manufacture.The supplier of the device has been contacted and will conduct an investigation on the device.
 
Event Description
It was reported that after changing to this product, an occlusion alarm went off.No adverse affects.
 
Manufacturer Narrative
Other text: , corrected data: see b5.
 
Event Description
The complaint device is a purchased finished good and is not manufactured by smiths medical (manufacturer is vbm medintechnik gmbh).The responsible manufacturer is the owner of the design of the finished good and is responsible for regulatory reporting to the fda.No further reports will be filed by smiths medical for this event.
 
Manufacturer Narrative
Additional information: d4, h6 and h10 this remediation mdr was generated under protocol b10010116, as a result of warning letter cms#617147.The evaluation found no failure of the returned product.The device functioned as normal, and the air tightness was ok.The root cause of the reported issue was not determined., corrected data: d1 correction- brand name.
 
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Brand Name
INTUBATION- PORTEX ENDOTRACHEAL TUBE
Type of Device
INTUBATION CONNECTOR ACCESSORY
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
Manufacturer (Section G)
NULL
boundary road
hythe, kent CT21 6JL
UK   CT21 6JL
Manufacturer Contact
david halverson
6000 nathan lane north
akasaka, minato-ku, tokyo
minneapolis, MN 55442
MDR Report Key12700268
MDR Text Key280705001
Report Number3012307300-2021-10271
Device Sequence Number1
Product Code OKS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 05/26/2023
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 Model Number54-05-112
Device Catalogue Number54-05-112
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/27/2021
Initial Date FDA Received10/26/2021
Supplement Dates Manufacturer Received01/03/2022
04/21/2023
Supplement Dates FDA Received01/03/2022
05/26/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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