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

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.

• 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 Key: 12700268
• MDR Text Key: 280705001
• Report Number: 3012307300-2021-10271
• Device Sequence Number: 1
• Product Code: OKS
• 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,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 Number: 54-05-112
• Device Catalogue Number: 54-05-112
• 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 Received: 10/26/2021
• Supplement Dates Manufacturer Received: 01/03/2022; 04/21/2023
• Supplement Dates FDA Received: 01/03/2022; 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 Number: 1